| Bevacizumab | US FDA | Malignant Peritoneal Neoplasm | Epithelial ovarian, fallopian tube, or primary peritoneal cancer: in combination with carboplatin and paclitaxel, followed by Avastin as a single agent, for stage III or IV disease following initial surgical resection | approved | Feb 26, 2004 | openfda |
| Bevacizumab | US FDA | Malignant Colorectal Neoplasm | Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen. | approved | Feb 26, 2004 | openfda |
| Bexarotene | EU EMA | Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | Targretin capsules are indicated for the treatment of skin manifestations of advanced stage cutaneous T-cell lymphoma (CTCL) patients refractory to at least one systemic treatment. | approved | Mar 29, 2001 | ema |
| Bexarotene | US FDA | Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | Targretin (bexarotene) gel 1% is indicated for the topical treatment of cutaneous lesions in patients with CTCL (Stage IA and IB) who have refractory or persistent disease after other therapies or who have not tolerated other therapies. | approved | Jun 28, 2000 | openfda |
| Bexarotene | US FDA | Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | TARGRETIN ® (bexarotene) Capsules are indicated for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy. TARGRETIN (bexarotene) is a retinoid indicated for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy. ( 1 ) | approved | Dec 29, 1999 | openfda |
| Bicalutamide | US FDA | Prostate Carcinoma | 1. INDICATIONS AND USAGE Bicalutamide tablets 50 mg daily is indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D 2 metastatic carcinoma of the prostate. Bicalutamide tablets 150 mg daily is not approved for use alone or with other treatments [see Clinical Studies (14.2) ]. Bicalutamide tablets 50 mg is an androgen receptor inhibitor indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D 2 metastatic carcinoma of the prostate. (1) Bicalutamide tablets 150 mg daily is not approved for use alone or with other treatments. (1) | approved | Oct 4, 1995 | openfda |
| Binimetinib | US FDA | Melanoma | in combination with encorafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. | approved | Jun 27, 2018 | openfda |
| Binimetinib | US FDA | Lung Non-Small Cell Carcinoma | in combination with encorafenib, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. | approved | Jun 27, 2018 | openfda |
| Blinatumomab | EU EMA | Acute Lymphoblastic Leukemia | Blincyto is indicated as monotherapy for the treatment of adults with CD19 positive relapsed or refractory B‑cell precursor acute lymphoblastic leukaemia (ALL). Patients with Philadelphia chromosome-positive B-cell precursor ALL should have failed treatment with at least 2 tyrosine kinase inhibitors (TKIs) and have no alternative treatment options. Blincyto is indicated as monotherapy for the treatment of adults with Philadelphia chromosome-negative CD19 positive B-cell precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. Blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 month or older with Philadelphia chromosome-negative CD19 positive B‑cell precursor ALL which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic haematopoietic stem cell transplantation. Blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 month or older with high-risk first relapsed Philadelphia chromosome-negative CD19 positive B-cell precursor ALL as part of the consolidation therapy (see section 4.2). Blincyto is indicated as monotherapy as part of consolidation therapy for the treatment of adult patients with newly diagnosed Philadelphia chromosome negative CD19 positive B-cell precursor ALL. | approved | Nov 23, 2015 | ema |
| Blinatumomab | US FDA | Acute Lymphoblastic Leukemia | CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. | approved | Dec 3, 2014 | openfda |
| Blinatumomab | US FDA | Acute Lymphoblastic Leukemia | CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (ALL) in the consolidation phase of multiphase chemotherapy. | approved | Dec 3, 2014 | openfda |
| Blinatumomab | US FDA | Acute Lymphoblastic Leukemia | Relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL). | approved | Dec 3, 2014 | openfda |
| Bortezomib | US FDA | Multiple Myeloma | treatment of adult patients with multiple myeloma | approved | Aug 26, 2024 | openfda |
| Bortezomib | US FDA | Mantle Cell Lymphoma | treatment of adult patients with mantle cell lymphoma | approved | Aug 26, 2024 | openfda |
| Bortezomib | US FDA | Mantle Cell Lymphoma | treatment of adult patients with mantle cell lymphoma | approved | Jul 27, 2022 | openfda |
| Bortezomib | US FDA | Multiple Myeloma | treatment of adult patients with multiple myeloma | approved | Jul 27, 2022 | openfda |
| Bortezomib | US FDA | Mantle Cell Lymphoma | Treatment of adult patients with mantle cell lymphoma. | approved | May 2, 2022 | openfda |
| Bortezomib | US FDA | Multiple Myeloma | Treatment of adult patients with multiple myeloma. | approved | May 2, 2022 | openfda |
| Bortezomib | US FDA | Mantle Cell Lymphoma | treatment of adult patients with mantle cell lymphoma | approved | May 13, 2003 | openfda |
| Bortezomib | US FDA | Multiple Myeloma | treatment of adult patients with multiple myeloma | approved | May 13, 2003 | openfda |
| Bosutinib | EU EMA | Chronic Myeloid Leukemia, Philadelphia Chromosome Negative, BCR-ABL1 Positive | Bosulif is indicated for the treatment of:• Adult and paediatric patients aged 6 years and older with newly-diagnosed (ND) chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukaemia (Ph+ CML).• Adult and paediatric patients aged 6 years and older with CP Ph+ CML previously treated with one or more tyrosine kinase inhibitor(s) [TKI(s)] and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.• Adult patients with accelerated phase (AP), and blast phase (BP) Ph+ CML previously treated with one or more tyrosine kinase inhibitor(s) [TKI(s)] and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options. | approved | Mar 27, 2013 | ema |
| Bosutinib | US FDA | Chronic Myeloid Leukemia, Philadelphia Chromosome Negative, BCR-ABL1 Positive | adult and pediatric patients 1 year of age and older with chronic phase Ph+ chronic myelogenous leukemia (CML), newly-diagnosed or resistant or intolerant to prior therapy. ( 1 ) | approved | Sep 26, 2023 | openfda |
| Bosutinib | US FDA | Chronic Myeloid Leukemia, Philadelphia Chromosome Negative, BCR-ABL1 Positive | adult and pediatric patients 1 year of age and older with chronic phase Ph+ chronic myelogenous leukemia (CML), newly-diagnosed or resistant or intolerant to prior therapy. ( 1 ) | approved | Sep 4, 2012 | openfda |
| Brentuximab Vedotin | EU EMA | Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | Hodgkin lymphomaAdcetris is indicated for adult patients with previously untreated CD30+ Stage IV Hodgkin lymphoma (HL) in combination with doxorubicin, vinblastine and dacarbazine (AVD).Adcetris is indicated for adult patients with previously untreated CD30+ Stage IIB with risk factors, Stage III or Stage IV HL in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine, dexamethasone (BrECADD).Adcetris is indicated for the treatment of adult patients with CD30+ HL at increased risk of relapse or progression following autologous stem cell transplant (ASCT).Adcetris is indicated for the treatment of adult patients with relapsed or refractory CD30+ Hodgkin lymphoma (HL):- following ASCT, or- following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option.Systemic anaplastic large cell lymphomaAdcetris in combination with cyclophosphamide, doxorubicin and prednisone (CHP) is indicated for adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL). Adcetris is indicated for the treatment of adult patients with relapsed or refractory sALCL.Cutaneous T-cell lymphomaAdcetris is indicated for the treatment of adult patients with CD30+ cutaneous T-cell lymphoma (CTCL) after at least 1 prior systemic therapy. | approved | Oct 25, 2012 | ema |
| Brentuximab Vedotin | US FDA | Classic Hodgkin Lymphoma | . • Adult patients with classical Hodgkin lymphoma (cHL) at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation | approved | Aug 19, 2011 | openfda |
| Brentuximab Vedotin | US FDA | Classic Hodgkin Lymphoma | Adult patients with previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vinblastine, and dacarbazine | approved | Aug 19, 2011 | openfda |
| Brentuximab Vedotin | US FDA | Classic Hodgkin Lymphoma | . • Pediatric patients 2 years and older with previously untreated high risk classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide | approved | Aug 19, 2011 | openfda |
| Brentuximab Vedotin | US FDA | Classic Hodgkin Lymphoma | . • Adult patients with classical Hodgkin lymphoma (cHL) after failure of auto-HSCT or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates | approved | Aug 19, 2011 | openfda |
| Brentuximab Vedotin | US FDA | Systemic Anaplastic Large Cell Lymphoma | . • Adult patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen | approved | Aug 19, 2011 | openfda |
| Busulfan | US FDA | Myeloid Leukemia | MYLERAN (busulfan) is indicated for the palliative treatment of chronic myelogenous (myeloid, myelocytic, granulocytic) leukemia. | approved | Jun 26, 1954 | openfda |
| Cabazitaxel | EU EMA | Malignant Prostate Neoplasm | Treatment of patients with hormone refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen. | approved | Aug 28, 2020 | ema |
| Cabazitaxel | EU EMA | Malignant Prostate Neoplasm | Jevtana in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen. | approved | Mar 17, 2011 | ema |
| Cabazitaxel | US FDA | Castration-Resistant Prostate Carcinoma | JEVTANA ® is indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen. JEVTANA is a microtubule inhibitor indicated in combination with prednisone for treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen. ( 1 ) | approved | Jun 17, 2010 | openfda |
| Cabozantinib | EU EMA | Renal Cell Carcinoma | Renal Cell Carcinoma (RCC) Cabometyx is indicated as monotherapy for advanced renal cell carcinoma as first-line treatment of adult patients with intermediate or poor risk, in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy. Cabometyx, in combination with nivolumab, is indicated for the first-line treatment of advanced renal cell carcinoma in adults. Hepatocellular carcinoma (HCC)Cabometyx is indicated as monotherapy for the treatment of hepatocellular carcinoma (HCC) in adults who have previously been treated with sorafenib.Differentiated thyroid carcinoma (DTC)Cabometyx is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic differentiated thyroid carcinoma (DTC), refractory or not eligible to radioactive iodine (RAI) who have progressed during or after prior systemic therapy.Neuroendocrine Tumours (NET)Cabometyx is indicated for the treatment of adult patients with unresectable or metastatic, well differentiated extra-pancreatic (epNET) and pancreatic (pNET) neuroendocrine tumours who have progressed following at least one prior systemic therapy other than somatostatin analogues.accelerated | approved | Sep 9, 2016 | ema |
| Cabozantinib | EU EMA | Thyroid Gland Medullary Carcinoma | Treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma. | approved | Mar 21, 2014 | ema |
| Cabozantinib | US FDA | Renal Cell Carcinoma | patients with advanced renal cell carcinoma, as a first-line treatment in combination with nivolumab | approved | Apr 25, 2016 | openfda |
| Cabozantinib | US FDA | Hepatocellular Carcinoma | patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib | approved | Apr 25, 2016 | openfda |
| Cabozantinib | US FDA | Renal Cell Carcinoma | CABOMETYX is a kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma (RCC). | approved | Apr 25, 2016 | openfda |
| Cabozantinib | US FDA | Primitive Neuroectodermal Tumor | adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNET). | approved | Apr 25, 2016 | openfda |
| Cabozantinib | US FDA | Malignant Thyroid Gland Neoplasm | adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior VEGFR-targeted therapy and who are radioactive iodine-refractory or ineligible | approved | Apr 25, 2016 | openfda |
| Cabozantinib | US FDA | Thyroid Gland Medullary Carcinoma | COMETRIQ is indicated for the treatment of patients with progressive, metastatic medullary thyroid cancer (MTC). COMETRIQ is a kinase inhibitor indicated for the treatment of patients with progressive, metastatic medullary thyroid cancer (MTC). ( 1 ) | approved | Nov 29, 2012 | openfda |
| Calaspargase Pegol | US FDA | Acute Lymphoblastic Leukemia | ASPARLAS is an asparagine specific enzyme indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia in pediatric and young adult patients age 1 month to 21 years. | approved | Dec 20, 2018 | openfda |
| Camizestrant | US FDA | Malignant Breast Neoplasm | in combination with a CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) for the treatment of adult patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, locally advanced or metastatic breast cancer upon detection of ESR1 mutation during aromatase inhibitor and CDK4/6 inhibitor therapy, based on an FDA authorized test. ( 1 , 2.1 ) This indication is approved under accelerated approval based on progression-free survival as measured from detection of ESR1 mutation. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1 )accelerated | approved | Sep 4, 2026 | openfda |
| Capecitabine | US FDA | Malignant Breast Neoplasm | treatment of patients with advanced or metastatic breast cancer in combination with docetaxel after disease progression on prior anthracycline-containing chemotherapy. | approved | Apr 30, 1998 | openfda |
| Capecitabine | US FDA | Malignant Colon Neoplasm | Colorectal Cancer adjuvant treatment of patients with Stage III colon cancer as a single agent or as a component of a combination chemotherapy regimen. | approved | Apr 30, 1998 | openfda |
| Capecitabine | US FDA | Malignant Breast Neoplasm | Breast Cancer treatment of patients with advanced or metastatic breast cancer as a single agent if an anthracycline- or taxane-containing chemotherapy is not indicated. | approved | Apr 30, 1998 | openfda |
| Capecitabine | US FDA | Malignant Colorectal Neoplasm | treatment of patients with unresectable or metastatic colorectal cancer as a single agent or as a component of a combination chemotherapy regimen. | approved | Apr 30, 1998 | openfda |
| Capecitabine | US FDA | Gastroesophageal Junction Adenocarcinoma | treatment of adults with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease as a component of a combination regimen. | approved | Apr 30, 1998 | openfda |
| Capecitabine | US FDA | Pancreatic Adenocarcinoma | Pancreatic Cancer adjuvant treatment of adults with pancreatic adenocarcinoma as a component of a combination chemotherapy regimen. | approved | Apr 30, 1998 | openfda |
| Capecitabine | US FDA | Malignant Rectal Neoplasm | perioperative treatment of adults with locally advanced rectal cancer as a component of chemoradiotherapy. | approved | Apr 30, 1998 | openfda |