|DB00002||Cetuximab||Cetuximab, used in combination with irinotecan, is indicated for the treatment of EGFR-expressing, metastatic colorectal carcinoma in patients who are refractory to irinotecan-based chemotherapy. Cetuximab administered as a single agent is indicated for the treatment of EGFR-expressing, metastatic colorectal carcinoma in patients who are intolerant to irinotecan-based chemotherapy.|
|DB00005||Etanercept||Etanercept is indicated for the treatment of moderately to severely active rheumatoid arthritis in adults and chronic moderate to severe plaque psoriasis in adults. It is also used to manage signs and symptoms of polyarticular idiopathic arthritis in those aged 4 to 17 after insufficient response to one or more disease-modifying anti-rheumatic drugs. Etanercept is also used to improve psoriatic arthritis and ankylosing spondylitis. |
|DB00028||Immune Globulin Human||IVIg is used in the treatment of immunodeficiencies, as well as autoimmune and inflammatory disorders. These indications includes idiopathic thrombocytopenic purpura, Kawasaki disease, hypogammaglobulinemia, B cell chronic lymphocytic leukemia, bone marrow transplant complications, Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy (CIDP), multiple sclerosis, rheumatoid arthritis, myesthenia gravis, Wiskott–Aldrich syndrome and inflammatory skin diseases.|
|DB00043||Omalizumab||This drug is an anti-IgE antibody indicated for:
1. Moderate to severe persistent asthma in patients 6 years of age and older
with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids [FDA label]
2. Chronic idiopathic urticaria in adults and adolescents 12 years of age and older who remain symptomatic despite H1 antihistamine treatment [FDA label]|
|DB00051||Adalimumab||The following are conditions for which adalimumab has been indicated [F2118], [FDA label], [L4805], [A40001], [A40002], [L4806].
Rheumatoid Arthritis (Moderate to Severe)
Juvenile Idiopathic Arthritis (Moderately to Severely Active)
Psoriatic Arthritis (Active)
Ankylosing Spondylitis (Active)
Crohn’s Disease (Moderately to Severely Active)
Ulcerative Colitis (Moderately to Severely Active)
Plaque Psoriasis (Moderate to Severe Chronic)
Non-infectious Intermediate, Posterior and Panuveitis
Hidradenitis Suppurativa (Moderate to Severe)
Pyoderma Gangrenosum (off-label)
|DB00054||Abciximab||Abciximab is indicated as an adjunct to percutaneous coronary intervention for the prevention of cardiac ischemic complications in patients undergoing percutaneous coronary intervention and in patients with unstable angina not responding to conventional medical therapy when percutaneous coronary intervention is planned within 24 hours. Abciximab is intended for use with aspirin and heparin and has been studied only in that setting.|
|DB00056||Gemtuzumab ozogamicin||Indicated for the treatment of patients with CD33 positive acute myeloid leukemia in first relapse who are 60 years of age or older and who are not considered candidates for other cytotoxic chemotherapy. Indicated for the treatment of patients aged 2 years and older with CD33-positive AML who have experienced a relapse or who have not responded to initial treatment (refractory). |
|DB00057||Indium In-111 satumomab pendetide||For diagnosis of extrahepatic malignant cancers|
|DB00065||Infliximab||* Indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult or pediatric (≥ 6 years of age) patients with moderately to severely active **Crohn’s disease** who have had an inadequate response to conventional therapy
* Indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing **Crohn’s disease**.
* Indicated for reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult or pediatric (≥ 6 years of age) patients with moderately to severely active **ulcerative colitis** who have had an inadequate response to conventional therapy.
* Indicated for, in combination with methotrexate, reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active **rheumatoid arthritis**.
* Indicated for reducing signs and symptoms in patients with active **ankylosing spondylitis**.
* Indicated for reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in patients with **psoriatic arthritis**.
* Indicated for the treatment of adult patients with chronic severe (i.e., extensive and/or disabling) **plaque psoriasis** who are candidates for systemic therapy and when other systemic therapies are medically less appropriate.|
|DB00072||Trastuzumab||Indicated for treatment of early stage HER2-positive breast cancer, or metastatic breast cancer that substantially overexpress HER2. The intravenous powder for solution, OGIVRI, is approved in Canada for early breast cancer, metastatic breast cancer, and gastric cancer, provided these cancers overexpress HER2[L6214].|
|DB00073||Rituximab||Rituximab is indicated in the following conditions [FDA label]:
**Non–Hodgkin’s Lymphoma (NHL)**
**Chronic Lymphocytic Leukemia (CLL)**
**Rheumatoid Arthritis (RA) in combination with methotrexate in adult patients with moderately-to severely-active RA**
**Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA)**
**Moderate to severe Pemphigus Vulgaris (PV) in adult patients**
The biosimilar (approved in November 2018), _Truxima_, is indicated For the treatment of adult patients with CD20-positive, B-cell non-Hodgkin’s lymphoma (NHL) to be used as a single agent or in combination with chemotherapy [L4808].|
|DB00074||Basiliximab||For prophylactic treatment of kidney transplant rejection|
|DB00075||Muromonab||For treatment of organ transplant recipients, prevention of organ rejection|
|DB00078||Ibritumomab tiuxetan||For treatment of non-Hodgkin's lymphoma|
|DB00081||Tositumomab||For treatment of non-Hodgkin's lymphoma (CD20 positive, follicular)|
|DB00087||Alemtuzumab||Alemtuzumab (Campath) is a monoclonal antibody therapy used for treatment of B-cell chronic lymphocytic leukemia.|
|DB00089||Capromab pendetide||For diagnosis of prostate cancer and detection of intra-pelvic metastases.|
|DB00095||Efalizumab||For the treatment of adult patients with moderate to severe chronic plaque psoriasis, who are candidates for phototherapy or systemic therapy.|
|DB00098||Antithymocyte immunoglobulin (rabbit)||For prevention of renal transplant rejection|
|DB00108||Natalizumab||For treatment of multiple sclerosis.|
|DB00110||Palivizumab||For prophylaxis of respiratory diseases casued by respiratory syncytial virus.|
|DB00111||Daclizumab||Zenapax is a humanized monoclonal antibody used for prevention of renal transplant rejection|
|DB00112||Bevacizumab||As part of combination therapy for metastatic colorectal cancer and HER2-negative metastatic breast cancer.|
|DB00113||Technetium Tc-99m arcitumomab||For imaging colorectal tumors|
|DB01257||Eculizumab||For the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis.|
|DB01269||Panitumumab||For the treatment of EGFR-expressing, metastatic colorectal carcinoma that is refractory to fluoropyrimidine-, oxaliplatin-, and irinotecan- containing chemotherapy regimens.|
|DB01270||Ranibizumab||For the treatment of patients with macular edema after retinal vein occlusion, age-related macular degeneration (wet), and diabetic macular edema.
|DB01281||Abatacept||For the management of the signs and symptoms of moderate-to-severe active rheumatoid arthritis, inducing major clinical response, slowing the progression of structural damage, and improving physical function in adult patients. It is indicated both as a monotherapy and for use in combination with a continued regimen of DMARDs (not including TNF antagonists). Also used for the management of the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in children.|
|DB04901||Galiximab||Investigated for use/treatment in lymphoma (non-hodgkin's), psoriasis and psoriatic disorders, bone metastases, multiple myeloma, prostate cancer, and rheumatoid arthritis.|
|DB04949||Pexelizumab||For the treatment of inflammation during cardiac surgery.|
|DB04956||Afelimomab||Investigated for use/treatment in sepsis and septicemia.|
|DB04958||Epratuzumab||Investigated for use/treatment in leukemia (lymphoid), lymphoma (non-hodgkin's), and systemic lupus erythematosus.|
|DB04962||Bectumomab||Investigated for use/treatment in lymphoma (non-hodgkin's).|
|DB04964||Oregovomab||Investigated for use/treatment in ovarian cancer.|
|DB04988||IGN311||Intended for the treatment of various forms of cancer.|
|DB05006||Adecatumumab||Investigated for use/treatment in breast cancer and prostate cancer.|
|DB05097||Labetuzumab||Labetuzumab is a humanized monoclonal antibody used to treat cancer. Retrieved from "http://en.wikipedia.org/wiki/Labetuzumab"|
|DB05101||Matuzumab||Investigated for use/treatment in cervical dysplasia/cancer, colorectal cancer, gastric cancer, and lung cancer.|
|DB05111||Fontolizumab||Investigated for use/treatment in crohn's disease and psoriasis and psoriatic disorders.|
|DB05136||Bavituximab||Investigated for use/treatment in breast cancer, cancer/tumors (unspecified), HIV infection, hepatitis (viral, C), and solid tumors.|
|DB05139||CR002||Investigated for use/treatment in nephropathy.|
|DB05209||Rozrolimupab||Investigated for use/treatment in thrombocytopenia.|
|DB05336||Obiltoxaximab||Investigated for use/treatment in anthrax exposure, bacterial infection, crohn's disease, and graft versus host disease.|
|DB05405||XTL-001||Investigated for use/treatment in hepatitis (viral, B).|
|DB05437||NAV 1800||Investigated for use/treatment in colorectal cancer and solid tumors.|
|DB05459||Briakinumab||Investigated for use/treatment in autoimmune diseases, crohn's disease, multiple sclerosis, psoriasis and psoriatic disorders, and rheumatoid arthritis.|
|DB05496||Otelixizumab||Investigated for use/treatment in diabetes mellitus type 1, pediatric indications, and psoriasis and psoriatic disorders.|
|DB05545||AMG 108||Investigated for use/treatment in osteoarthritis and rheumatoid arthritis.|
|DB05550||Iratumumab||Investigated for use/treatment in lymphoma (unspecified).|
|DB05555||Enokizumab||Investigated for use/treatment in asthma.|
|DB05578||Ramucirumab||For use in advanced gastric or gastro-esophageal junction adenocarcinoma as a single agent or in combination with paclitaxel after prior fluoropyrimidine- or platinum-containing chemotherapy.|
|DB05595||Farletuzumab||Investigated for use/treatment in ovarian cancer.|
|DB05656||Veltuzumab||Investigated for use/treatment in lymphoma (non-hodgkin's).|
|DB05679||Ustekinumab||Ustekinumab is indicated for management of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy; or is used alone or in conjunction with methotrexate for the management of active psoriatic arthritis in adults. The FDA approved the use of ustekinumab in September 2016 for the treatment of moderate to severe Crohn's disease. The use of ustekinumab may improve short term clinical response but not clinical remission in moderate to severe Crohn's disease.|
|DB05773||Trastuzumab emtansine||Used in HER2-positive, metastatic breast cancer patients who have already used taxane and/or trastuzumab for metastatic disease or had their cancer recur within 6 months of adjuvant treatment.
|DB05797||TNX-901||Investigated for use/treatment in allergic reaction.|
|DB05889||Inotuzumab ozogamicin||Indicated as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B cell precursor acute lymphoblastic leukaemia (ALL). |
|DB05892||RI 624||Investigated for use/treatment in pain (acute or chronic).|
|DB05941||Leronlimab||Investigated for use/treatment in HIV infection.|
|DB05996||Glembatumumab vedotin||Investigated for use/treatment in melanoma.|
|DB06043||Olaratumab||Olaratumab is indicated, in combination with doxorubicin, for the treatment of adult patients with advanced or mestastatic soft tissue sarcoma (STS) with a histologic subtype for which an anthracycline-containing regimen is appropriate and which is not amenable to curative treatment with radiotherapy or surgery.|
|DB06049||IPH 2101||Investigated for use/treatment in leukemia (myeloid) and multiple myeloma.|
|DB06050||TB-402||Investigated for use/treatment in atrial fibrillation and thrombosis.|
|DB06116||Eldelumab||Investigated for use/treatment in ulcerative colitis.|
|DB06162||Lumiliximab||Investigated for use/treatment in asthma and leukemia (lymphoid).|
|DB06168||Canakinumab||Used in patients 4 years of age and older to treat Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS), which are both part of the Cryopyrin-Associated Periodic Syndromes (CAPS) as well as for patients 2 years of age and older to treat systemic juvenile idiopathic arthritis (SJIA). |
|DB06186||Ipilimumab||Ipilimumab is approved for different conditions such as:
* Treatment of unresectable or metastatic melanoma in patients 12 years and older.
* Adjuvant treatment of patients with cutaneous melanoma with the pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection, including total lymphadenectomy.[FDA label]
In combination with [nivolumab], ipilimumab is approved for:
* Treatment of patients with intermediate or poor risk, previously untreated advanced renal cell carcinoma
* Treatment of 12 years and older patients with MSI-H/dMMR metastatic colorectal cancer with progression after treatment with fluoropyrimidine, oxaliplatin, and irinotecan.[FDA label]|
|DB06192||Nimotuzumab||Investigated for use/treatment in head and neck cancer, brain cancer, pediatric indications, pancreatic cancer, lung cancer, and colorectal cancer.|
|DB06241||Clenoliximab||Investigated for use/treatment in rheumatoid arthritis.|
|DB06273||Tocilizumab||Indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs). It is also indicated for the treatment of active polyarticular juvenile idiopathic arthritis (PJIA) and active systemic juvenile idiopathic arthritis (SJIA) in patients 2 years of age and older.|
|DB06304||BIIB015||Investigated for use/treatment in solid tumors.|
|DB06310||Motavizumab||Investigated for use/treatment in viral infection and pediatric indications.|
|DB06317||Elotuzumab||Indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior therapies.|
|DB06318||AVE9633||Investigated for use/treatment in leukemia (myeloid).|
|DB06322||Carotuximab||Investigated for use/treatment in solid tumors.|
|DB06324||XmAb 2513||Investigated for use/treatment in lymphoma (unspecified) and lymphoma (non-hodgkin's).|
|DB06342||Coltuximab ravtansine||Investigated for use/treatment in lymphoma (non-hodgkin's).|
|DB06343||Teprotumumab||Investigated for use/treatment in solid tumors.|
|DB06360||Lucatumumab||Investigated for use/treatment in leukemia (lymphoid), multiple myeloma, and lymphoma (unspecified).|
|DB06366||Pertuzumab||Pertuzumab is indicated for use in combination with trastuzumab and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.|
|DB06371||Siplizumab||Investigated for use/treatment in psoriasis and psoriatic disorders, transplant (rejection), graft versus host disease, lymphoma (unspecified), and leukemia (unspecified).|
|DB06467||Apolizumab||Investigated for use/treatment in lymphoma (non-hodgkin's), leukemia (lymphoid), and solid tumors.|
|DB06474||Sibrotuzumab||Investigated for use/treatment in cancer/tumors (unspecified), colorectal cancer, and lung cancer.|
|DB06550||Bivatuzumab||Investigated for use/treatment in cancer/tumors (unspecified) and head and neck cancer.|
|DB06557||Lerdelimumab||Investigated for use/treatment in glaucoma and cataracts.|
|DB06599||Lexatumumab||Investigated for use/treatment in cancer/tumors (unspecified).|
|DB06602||Reslizumab||Indicated for the add-on maintenance treatment of patients with severe asthma aged 18 years and older with an eosinophilic phenotype.|
|DB06606||Teplizumab||Investigated for use/treatment in diabetes mellitus type 1.|
|DB06607||Catumaxomab||For use in the management of malignant ascites tumours via intraperitoneal infusion where standard therapy is not available or feasible [FDA Label].|
|DB06612||Mepolizumab||Mepolizumab is indicated for add-on maintenance treatment of severe eosinophilic asthma, as identified by blood eosinophils greater than or equal to 150 cells/μl at initiation of treatment or blood eosinophils greater than or equal to 300 cells/μl in the past 12 months, in patients aged 12 years and older. Mepolizumab has been shown to reduce exacerbations of asthma in patients with an exacerbation history|
|DB06643||Denosumab||Prolia is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture. It reduces the incidence of vertebral, nonvertebral, and hip fractures. Prolia is also indicated as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. It can also be used in men with osteoporosis at high risk for fracture or in men receiving androgen deprivation therapy for nonmetastatic prostate cancer to increase bone mass. Xgeva is indicated for the prevention of skeletal-related events in patients with bone metastases from solid tumors.|
|DB06647||Volociximab||Investigated for use/treatment in solid tumors, renal cell carcinoma, melanoma, pancreatic cancer, lung cancer, and ovarian cancer.|
|DB06650||Ofatumumab||Ofatumumab is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) refractory to fludarabine and alemtuzumab.|
|DB06674||Golimumab||Used in adults (i) as an adjunct to methotrexate treatment in patients with moderate to severe active rheumatoid arthritis (RA), (ii) alone or as an adjunct to methotrexate treatment in patients with active psoriatic arthritis (PsA), (iii) as a single agent in patients with active ankylosing spondylitis (AS), and (iv) as a single agent in patients with moderate to severe ulcerative colitis (UC) who require chronic steroids or have experienced intolerance or only a partial response to previous medications.|
|DB06681||Belatacept||For prophylaxis of organ rejection. It is also used concomitantly with basiliximumab for induction therapy, mycophenolate, and corticosteriods in kidney transplant recepients that are seropositive for the Epstein-Barr virus. |
|DB08870||Brentuximab vedotin||Seattle Genetics Announced FDA Approval of ADCETRIS® (Brentuximab Vedotin) in combination with chemotherapy for adults with previously untreated stage III or IV Classical Hodgkin Lymphoma in March 2018 [L1737, L1739].
Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates [FDA label], [L1737].
Systemic anaplastic large cell lymphoma after failure of at least one prior multi-agent chemotherapy regimen [FDA label].|
|DB08879||Belimumab||Adjunct treatment for auto-antibody-positive active systemic lupus erythematosus (SLE). The intravenous injectable form is the only FDA approved treatment for pediatric patients with SLE.|
|DB08902||Raxibacumab||Raxibacumab is indicated for the treatment of adult and pediatric patients with inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs, and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate. |
|DB08904||Certolizumab pegol||Certolizumab pegol has been approved for several different conditions listed below:
- Symptomatic management of Chron's disease patients and for the maintenance of clinical response in patients with moderate to severe disease with inadequate response to conventional therapy.
- Treatment of adult patients with moderate to severely active rheumatoid arthritis.
- Treatment of adult patients with active psoriatic arthritis.
- Treatment of adult patients with active ankylosing spondylitis.
- Treatment of adult patients with moderate-to-severe plaque psoriasis that are candidates for systemic therapy or phototherapy.[FDA label]
- Treatment of adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation.[L5819]
In Canada, certolizumab pegol is additionally approved in combination with [methotrexate] for the symptomatic treatment, including major clinical response, and for the reduction of joint damage in adult patients with moderately to severely active rheumatoid arthritis and psoriatic arthritis.[L5825]
Inflammation is a biological response against a potential threat. This response can be normal but in certain conditions, the immune system can attack the body's normal cells or tissues which causes an abnormal inflammation.[L5840] TNF-alpha has been identified as a key regulator of the inflammatory response. The signaling cascades of this inflammatory mediator can produce a wide range of reactions including cell death, survival, differentiation, proliferation and migration.[A176660] |
|DB08935||Obinutuzumab||Obinutuzumab is used as a combination treatment with chlorambucil to treat patients with untreated chronic lymphocytic leukemia.|
|DB09029||Secukinumab||For the treatment of moderate to severe plaque psoriasis in patients that are candidates for systemic therapy or phototherapy. |
|DB09033||Vedolizumab||Vedolizumab is indicated for adult patients with moderately to severely active UC or CD who have had an inadequate response with, lost response to, or were intolerant to a tumor necrosis factor (TNF) blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids. |
|DB09035||Nivolumab||Nivolumab is indicated as a single agent for the treatment of:
* BRAF V600 wild-type unresectable or metastatic melanoma.
* BRAF V600 mutation-positive unresectable or metastatic melanoma.
* metastatic non-small cell lung cancer and progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on disease-specific FDA therapy.
* advanced renal cell carcinoma with prior anti-angiogenic therapy.
* classical Hodgkin lymphoma in adults that has relapsed or progressed after autologous hematopoietic stem cell transplantation and brentuximab vedotin or 3 or more lines of systemic therapy that includes autologous hematopoietic stem cell transplantation.
* recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after platinum-based therapy.
* locally advanced or metastatic urothelial carcinoma with disease progression during or after platinum-containing chemotherapy or disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
* microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer in patients 12 years or older that progressed following treatment with fluoropyrimidine, oxaliplatin and irinotecan.
* hepatocellular carcinoma previously treated with sorafenib.[FDA label]
In combination with [ipilimumab], nivolumab is indicated for the treatment of:
* unresectable or metastatic melanoma.
* melanoma with lymph node involvement or metastatic disease that has gone through complete resection.
* intermediate or poor risk, previously untreated advanced renal cell carcinoma.
* microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer in patients 12 years or older that progressed following treatment with fluoropyrimidine, oxaliplatin and irinotecan.[FDA label]|
|DB09036||Siltuximab||Siltuximab is indicated for the treatment of patients with multicentric Castleman's disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative. Siltuximab did not bind to virally produced IL-6 in a nonclinical study and was therefore not studied in patients with MCD who are HIV or HHV-8 positive.|
|DB09037||Pembrolizumab||Pembrolizumab is indicated for the treatment of:
-Patients with unresectable or metastatic melanoma.[FDA label]
-As a single therapy, pembrolizumab is indicated for first-line treatment of patients with metastatic non-small cell lung cancer whose tumors have high PD-L1 expression [(Tumor Proportion Score (TPS) ≥50%)] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.[F137]
-As a single therapy, pembrolizumab is indicated for first-line treatment of patients with metastatic non-small cell lung cancer whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to treatment.[F137]
The following indications present the status of accelerated approval based on tumor response rate and durability of the response and thus, the approval of this indications are contingent upon verification and description of clinical benefit in confirmatory trials.
-Patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS > 1) as determined by an FDA-approved test.[L2955]
-In combination with pemetrexed and carboplatin, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer.[F137]
-Patients with recurrent or metastatic head and neck squamous cell carcinoma with disease progression on or after platinum-containing chemotherapy.[F137]
-Treatment of adults and pediatric patients with refractory classical Hodgkin lymphoma or who have relapsed after 3 or more prior lines of therapy.[F137]
-Treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma or who have relapsed after 2 or more prior lines of therapy.[F137]
-Treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy.[F137]
-Patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy.[F137]
-Treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high or mismatch repair deficient with solid tumors that have progressed following previous treatment and colorectal cancer that has progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan.[F137]
-Patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 (CPS >1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy.[F137]|
|DB09052||Blinatumomab||Indicated for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).|
|DB09077||Dinutuximab||Dinutuximab is indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy. Despite a high clinical response seen after first-line treatment, the complete eradication of neuroblastoma is rarely achieved and the majority of patients with advanced disease suffer a relapse. Current strategies for treatment include immunotherapy with drugs such as dinutuximab to target surviving neuroblastoma cells and to prevent relapse.|
|DB09105||Asfotase alfa||Indicated for the treatment of patients with perinatal/infantile and juvenile onset hypophosphatasia (HPP). |
|DB09264||Idarucizumab||For use in patients treated with Dabigatran when reversal of the anticoagulant effects of dabigatran is needed for emergency surgery/urgent procedures and in life-threatening or uncontrolled bleeding.|
|DB09302||Alirocumab||Alirocumab is an antibody eliciting proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor activity that is indicated for:
(i) use in reducing the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease [F4591], and/or
(ii) use as an adjunct to diet or use alone or in combination with other lipid-lowering therapies (statins, ezetimibe, for example) for the treatment of adults with primary hyperlipidemia (including heterozygous familial hypercholesterolemia) to reduce low-density lipoprotein cholesterol (LDL-C) levels in the body [F4591].|
|DB09303||Evolocumab||For the treatment of heterozygous/homozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease in patients on maximum tolerated statin therapy requiring additional LDL-cholesterol lowering. |
|DB09312||Antilymphocyte immunoglobulin (horse)||For prevention of renal transplant rejection and for the treatment of aplastic anemia.|
|DB09331||Daratumumab||For the treatment of patients with multiple myeloma who have received at least three prior lines of therapy (a proteasome inhibitor (PI) and an immunomodulatory agent) or who are double-refractory to a PI and an immunomodulatory agent. This indication was approved by accelerated approval based on response rate.|
|DB09559||Necitumumab||Necitumumab is approved for use in combination with cisplatin and gemcitabine as a first-line treatment for metastatic squamous non-small cell lung cancer (NSCLC). It is not indicated for treatment of non-squamous NSCLC. |
|DB11569||Ixekizumab|| Ixekizumab is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. |
|DB11621||Human Varicella-Zoster Immune Globulin||Indicated for preventing and reducing the severity of chicken pox (varicella zoster virus) infections in high risk individuals within 4 days of exposure to varicella zoster virus.|
|DB11714||Durvalumab||Durvalumab is indicated for patients with urothelial carcinoma, such as urinary bladder, urethra or ureter cancer. Patients with prolonged disease progression due to failed platinum-based chemotherapy such as cisplatin and carboplatin are most likely to benefit from durvalumab treatment. Its clinical effectiveness is especially enhanced in PD-L1-positive patient groups [A19123]. |
|DB11767||Sarilumab||Indicated for modere to severe reactive RA in adult patients who are irresponsive, respond inadequately or present intolerance to disease-modifying anti-rheumatic drugs (DMARDs) or tumor necrosis factor (TNF) antagonists. It is indicated to be used in combination with methotrexate (MTX) or as a monotherapy when there is intolerance to MTX or MTX administration is inappropriate.|
|DB11776||Brodalumab||Brodalumab has been approved for the treatment of psoriasis vulgaris, psoriatic arthritis, pustular psoriasis and psoriatic erythroderma. |
|DB11834||Guselkumab||Indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.|
|DB11866||Romosozumab||Romosozumab is indicated for the treatment of osteoporosis in post menopausal women at high risk of fractures and also in patients with osteoperosis who are intolerant to other treatments or who have failed in other treatments[FDA Label].|
|DB11945||Avelumab||Indicated for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC). |
|DB11988||Ocrelizumab||Indicated for the treatment of adult patients with relapsing or primary progressive forms of multiple sclerosis [FDA Label].|
|DB12089||Lorvotuzumab mertansine||Not Available|
|DB12159||Dupilumab||Dupilumab is a monoclonal antibody designed for the treatment of atopic diseases such as eczema.|
|DB12240||Polatuzumab Vedotin||Not Available|
|DB12489||Mirvetuximab Soravtansine||Not Available|
|DB12498||Mogamulizumab||For the intravenous use for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy. This approval provides a new treatment option for patients with MF and is the first FDA approval of a drug specifically for Sézary Syndrome [FDA label].|
|DB12589||Dacetuzumab||Investigated for use/treatment in lymphoma (non-hodgkin's) and multiple myeloma.|
|DB12698||Ibalizumab||Indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in highly treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current antiretroviral regimen [FDA label].
The approval of Trogarzo was supported by a clinical trial of 40 treatment-experienced adults with MDR HIV-1 infection who persistently had elevated levels of HIV RNA in their blood despite heavy antiretroviral therapy. The majority of study patients had previously been treated with ≥10 antiretroviral medications [L1554].|
|DB12807||Naptumomab Estafenatox||Not Available|
|DB12893||Sacituzumab govitecan||Not Available|
|DB13923||Emicizumab||The main function of Emicizumab is the prevention of bleeding episodes. Thus, Emicizumab is approved for the routine prophylaxis to prevent or reduce the frequency of bleeding episodes of adult and pediatric patients with hemophilia A with or without Factor VIII inhibitors.[L4657]
Hemophilia A is a deficiency of coagulation Factor VIII which causes a serious bleeding disorder. The standard treatment is done with the administration of recombinant or serum-deriver Factor VIII which induces the formation of anti-factor VIII alloantibodies (Factor VIII inhibitors) and renders the standard treatment ineffective.[A31286]|
|DB13979||Besilesomab||Besilesomab is radiolabelled with sodium pertechnetate (Tc99m) solution to develop technetium (Tc99m) besilesomab solution. This solution is indicated in adults for scintigraphic imaging - in conjunction with other appropriate imaging modalities, when possible - in determining the location of inflammation/infection in peripheral bone in adults with suspected osteomyelitis [FDA Label]. When utilized as such, this medicinal product is for diagnostic use only [FDA Label].|
|DB14004||Tildrakizumab||Moderate-severe plaque psoriasis [L1858], [FDA label].|
|DB14039||Erenumab||Erenumab is indicated for the preventative treatment of migraine in adults [FDA Label].|
|DB14041||Fremanezumab||The ongoing trials for fremanezumab are for episodic and chronic migraine prevention and also for cluster headache [A33114].|
|DB14597||Lanadelumab||Lanadelumab is indicated for the prophylaxis treatment to prevent attacks in patients 12 years and older with hereditary angioedema.[L4537]
The hereditary angioedema (HEA) is an autosomal dominant disorder resulted from the presence of C1 deficiency. Some reports have indicated a high prevalence of cases that result from spontaneous mutations which can be inherited. This condition is manifested by attacks of subcutaneous or submucosal edema in the face, larynx, GI tract, limbs or genitalia. From all the types of attacks, the most serious is the laryngeal as it can compromise the airway. The rest of the attacks are accompanied by pain and considerable dysfunction.[A38679] |
|DB12023||Benralizumab||Benralizumab is indicated as a maintenance treatment of patients 12 years or older with severe asthma and an eosinophilic phenotype.[L1020] The pathology of severe asthma with eosinophilic phenotype is also denotated as TH2-high phenotype. The patients with this phenotype are characterized by the expression of IL-5 and IL-13, airway hyperresponsiveness, responsiveness to inhaled corticosteroids, high serum IgE and eosinophilia in blood and airway. In the TH2-high phenotype, IL-5 presents a central role as it is responsible for eosinophil differentiation, survival, activation and migration to the lungs.[A31295]|
|DB14724||Emapalumab||Emapalumab is indicated for the treatment of pediatric and adult patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance to conventional HLH therapy.[L4840]
The HLH condition is a hyperinflammatory status characterized by the overwhelming activation of normal T lymphocytes and macrophages which can lead to disturbances in the hematology profile and even death. As part of the condition profile, there have been reports proving a massive overexpression of interferon-gamma which is thought to drive the immune hyperactivation leading to organ failure.[A38676] This condition is usually developed and present the symptomatic profile within the first months or years of life. These symptoms consist of fever, enlarged liver or spleen and a lower number of blood cells.[L4840]|
|DB11595||Atezolizumab||For the treatment of patients with locally advanced or metastatic urothelial carcinoma who: 1) have disease progression during or following platinum-containing chemotherapy, and 2) have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.|
|DB05304||Girentuximab||Investigated for use/treatment in gall bladder cancer and renal cell carcinoma.|
|DB14762||Risankizumab||This drug is for the treatment of moderate-to-severe plaque psoriasis in adults who are eligible to receive systemic therapy or phototherapy based on their disease process.[FDA label]|