|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.|
|DB00072||Trastuzumab||For treatment of early stage HER2-positive breast cancer, or metastatic breast cancer that substantially overexpress HER2.|
|DB00073||Rituximab||For treatment of CD20-positive non-Hodgkins lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis.|
|DB00112||Bevacizumab||As part of combination therapy for metastatic colorectal cancer and HER2-negative metastatic breast cancer.|
|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.
|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.|
|DB08935||Obinutuzumab||Obinutuzumab is used as a combination treatment with chlorambucil to treat patients with untreated chronic lymphocytic leukemia.|
|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]|
|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). |
|DB00110||Palivizumab||For prophylaxis of respiratory diseases casued by respiratory syncytial virus.|
|DB00043||Omalizumab||For treatment of asthma caused by allergies|
|DB00051||Adalimumab||For treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and Crohn's disease.|
|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.|
|DB00075||Muromonab||For treatment of organ transplant recipients, prevention of organ rejection|
|DB00087||Alemtuzumab||Alemtuzumab (Campath) is a monoclonal antibody therapy used for treatment of B-cell chronic lymphocytic leukemia.|
|DB00108||Natalizumab||For treatment of multiple sclerosis.|
|DB00111||Daclizumab||Zenapax is a humanized monoclonal antibody used for prevention of renal transplant rejection|
|DB01257||Eculizumab||For the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis.|
|DB01270||Ranibizumab||For the treatment of patients with macular edema after retinal vein occlusion, age-related macular degeneration (wet), and diabetic macular edema.
|DB04949||Pexelizumab||For the treatment of inflammation during cardiac surgery.|
|DB04958||Epratuzumab||Investigated for use/treatment in leukemia (lymphoid), lymphoma (non-hodgkin's), and systemic lupus erythematosus.|
|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.|
|DB05496||Otelixizumab||Investigated for use/treatment in diabetes mellitus type 1, pediatric indications, and psoriasis and psoriatic disorders.|
|DB05555||Enokizumab||Investigated for use/treatment in asthma.|
|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.|
|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).|
|DB06116||Eldelumab||Investigated for use/treatment in ulcerative colitis.|
|DB06192||Nimotuzumab||Investigated for use/treatment in head and neck cancer, brain cancer, pediatric indications, pancreatic cancer, lung cancer, and colorectal cancer.|
|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.|
|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.|
|DB06342||Coltuximab ravtansine||Investigated for use/treatment in lymphoma (non-hodgkin's).|
|DB06360||Lucatumumab||Investigated for use/treatment in leukemia (lymphoid), multiple myeloma, and lymphoma (unspecified).|
|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.|
|DB06550||Bivatuzumab||Investigated for use/treatment in cancer/tumors (unspecified) and head and neck cancer.|
|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.|
|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.|
|DB08879||Belimumab||Adjunct treatment for auto-antibody-positive active systemic lupus erythematosus. |
|DB08904||Certolizumab pegol||Reducing signs and symptoms of Crohn's disease and treatment of moderately to severely active rheumatoid arthritis (RA). |
|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. |
|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.|
|DB11569||Ixekizumab|| Ixekizumab is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. |
|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.|
|DB11988||Ocrelizumab||Indicated for the treatment of adult patients with relapsing or primary progressive forms of multiple sclerosis [FDA Label].|
|DB12489||Mirvetuximab Soravtansine||Not Available|
|DB12589||Dacetuzumab||Investigated for use/treatment in lymphoma (non-hodgkin's) and multiple myeloma.|
|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 of patients with hemophilia A that present Factor VIII inhibitors. 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].|
|DB01269||Panitumumab||For the treatment of EGFR-expressing, metastatic colorectal carcinoma that is refractory to fluoropyrimidine-, oxaliplatin-, and irinotecan- containing chemotherapy regimens.|
|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.|
|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]|
|DB06607||Catumaxomab||For use in the management of malignant ascites tumours via intraperitoneal infusion where standard therapy is not available or feasible [FDA Label].|
|DB06650||Ofatumumab||Ofatumumab is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) refractory to fludarabine and alemtuzumab.|
|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].|
|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]|
|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.|
|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. |
|DB11731||Depatuxizumab mafodotin||No approved indication.|
|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.|