| Abemaciclib | US FDA | Malignant Breast Neoplasm | as monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting. | approved | Sep 28, 2017 | openfda |
| Abemaciclib | US FDA | Malignant Breast Neoplasm | in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. | approved | Sep 28, 2017 | openfda |
| Abemaciclib | US FDA | Malignant Breast Neoplasm | in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence. | approved | Sep 28, 2017 | openfda |
| Abemaciclib | US FDA | Malignant Breast Neoplasm | in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy. | approved | Sep 28, 2017 | openfda |
| Abiraterone | US FDA | Castration-Resistant Prostate Carcinoma | Abiraterone Acetate is indicated in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer. Abiraterone Acetate is a CYP17 inhibitor indicated in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC). ( 1 ) | approved | May 22, 2018 | openfda |
| Abiraterone Acetate | US FDA | Castration-Resistant Prostate Carcinoma | Abiraterone Acetate is indicated in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer. Abiraterone Acetate is a CYP17 inhibitor indicated in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC). ( 1 ) | approved | May 22, 2018 | openfda |
| Acalabrutinib | US FDA | Mantle Cell Lymphoma | In combination with bendamustine and rituximab for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT). | approved | Aug 3, 2022 | openfda |
| Acalabrutinib | US FDA | Mantle Cell Lymphoma | In combination with bendamustine and rituximab for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT). | approved | Aug 3, 2022 | openfda |
| Acalabrutinib | US FDA | Mantle Cell Lymphoma | In combination with bendamustine and rituximab for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT). | approved | Oct 31, 2017 | openfda |
| Adagrasib | US FDA | Malignant Colorectal Neoplasm | Colorectal cancer (CRC)* • In combination with cetuximab, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic CRC, as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. | approved | Dec 12, 2022 | openfda |
| Adagrasib | US FDA | Lung Non-Small Cell Carcinoma | Non-small cell lung cancer (NSCLC)* • As a single agent, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy. | approved | Dec 12, 2022 | openfda |
| Afatinib | US FDA | Lung Non-Small Cell Carcinoma | Treatment of patients with metastatic, squamous NSCLC progressing after platinum-based chemotherapy | approved | Jul 12, 2013 | openfda |
| Afatinib | US FDA | Lung Non-Small Cell Carcinoma | First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test | approved | Jul 12, 2013 | openfda |
| Aflibercept | US FDA | Malignant Colorectal Neoplasm | ZALTRAP, in combination with fluorouracil, leucovorin, irinotecan-(FOLFIRI), is indicated for the treatment of patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin-containing regimen. ZALTRAP, a vascular endothelial growth factor inhibitor, in combination with fluorouracil, leucovorin, irinotecan (FOLFIRI), is indicated for the treatment of patients with metastatic colorectal cancer that is resistant to or has progressed following an oxaliplatin-containing regimen. ( 1 ) | approved | Aug 3, 2012 | openfda |
| Aldesleukin | US FDA | Renal Cell Carcinoma | The treatment of adults with metastatic renal cell carcinoma. | approved | May 5, 1992 | openfda |
| Alectinib | US FDA | Lung Non-Small Cell Carcinoma | treatment of adult patients with ALK-positive metastatic NSCLC as detected by an FDA-approved test. | approved | Dec 11, 2015 | openfda |
| Alemtuzumab | US FDA | Chronic Lymphocytic Leukemia | CAMPATH is indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL). CAMPATH is a CD52-directed cytolytic antibody indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL). ( 1 ) | approved | May 7, 2001 | openfda |
| Alitretinoin | US FDA | AIDS-Related Kaposi Sarcoma | Kaposi’s Sarcoma PANRETIN GEL is indicated for topical treatment of cutaneous lesions in adults with AIDS related Kaposi’s sarcoma (KS). Limitations of Use: PANRETIN GEL is not indicated when systemic anti-KS therapy is required (including more than 10 new KS lesions in the prior month, symptomatic lymphedema, symptomatic pulmonary KS, or symptomatic visceral involvement) [see Clinical Studies ( 14.1 )] . PANRETIN GEL is a retinoid indicated for the topical treatment of cutaneous lesions in adults with AIDS-related Kaposi’s sarcoma (KS). Limitations of Use : PANRETIN GEL is not indicated when systemic anti-Kaposi’s sarcoma therapy is required. | approved | Feb 2, 1999 | openfda |
| Alpelisib | US FDA | Malignant Breast Neoplasm | PIQRAY is indicated in combination with fulvestrant for the treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen. PIQRAY is a kinase inhibitor indicated in combination with fulvestrant for the treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen. | approved | May 24, 2019 | openfda |
| Amivantamab | US FDA | Lung Non-Small Cell Carcinoma | Previously Treated NSCLC with EGFR Exon 19 Deletions or Exon 21 L858R Substitution Mutations RYBREVANT, in combination with carboplatin and pemetrexed, is indicated for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor [see Dosage and Administration (2.2) ] . | approved | May 21, 2021 | openfda |
| Amivantamab | US FDA | Lung Non-Small Cell Carcinoma | First-Line Treatment of NSCLC with EGFR Exon 20 Insertion Mutations RYBREVANT, in combination with carboplatin and pemetrexed, is indicated for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test [see Dosage and Administration (2.2) ] . | approved | May 21, 2021 | openfda |
| Amivantamab | US FDA | Lung Non-Small Cell Carcinoma | First-Line Treatment of NSCLC with EGFR Exon 19 Deletions or Exon 21 L858R Substitution Mutations RYBREVANT, in combination with lazertinib, is indicated for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test [see Dosage and Administration (2.2) ] . | approved | May 21, 2021 | openfda |
| Amivantamab | US FDA | Lung Non-Small Cell Carcinoma | Previously Treated NSCLC with EGFR Exon 20 Insertion Mutations RYBREVANT is indicated as a single agent for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test [see Dosage and Administration (2.2) ] , whose disease has progressed on or after platinum-based chemotherapy. | approved | May 21, 2021 | openfda |
| Anagrelide | US FDA | Myeloproliferative Neoplasm | AGRYLIN is indicated for the treatment of patients with thrombocythemia, secondary to myeloproliferative neoplasms, to reduce the elevated platelet count and the risk of thrombosis and to ameliorate associated symptoms including thrombo-hemorrhagic events. AGRYLIN is a platelet reducing agent indicated for the treatment of thrombocythemia, secondary to myeloproliferative neoplasms, to reduce the elevated platelet count and the risk of thrombosis and to ameliorate associated symptoms including thrombo-hemorrhagic events. ( 1 ) | approved | Mar 14, 1997 | openfda |
| Anastrozole | US FDA | Malignant Breast Neoplasm | Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to ARIMIDEX | approved | Dec 27, 1995 | openfda |
| Anastrozole | US FDA | Malignant Breast Neoplasm | Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer | approved | Dec 27, 1995 | openfda |
| Anastrozole | US FDA | Malignant Breast Neoplasm | First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic breast cancer | approved | Dec 27, 1995 | openfda |
| Apalutamide | US FDA | Nonmetastatic Castration-Resistant Prostate Carcinoma | ERLEADA is indicated for the treatment of patients with Metastatic castration-sensitive prostate cancer (mCSPC) Non-metastatic castration-resistant prostate cancer (nmCRPC) ERLEADA is an androgen receptor inhibitor indicated for the treatment of patients with metastatic castration-sensitive prostate cancer. ( 1 ) non-metastatic castration-resistant prostate cancer. ( 1 ) | approved | Feb 14, 2018 | openfda |
| Arsenic Trioxide | US FDA | Acute Promyelocytic Leukemia | In combination with tretinoin for treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. | approved | Sep 25, 2000 | openfda |
| Atezolizumab | US FDA | Lung Non-Small Cell Carcinoma | for the first-line treatment of adult patients with metastatic NSCLC whose tumors have high PD-L1 expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 10% of the tumor area [IC ≥ 10%] ), as determined by an FDA-authorized test, with no EGFR or ALK genomic tumor aberrations. | approved | May 18, 2016 | openfda |
| Atezolizumab | US FDA | Lung Non-Squamous Non-Small Cell Carcinoma | in combination with paclitaxel protein-bound and carboplatin for the first-line treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations | approved | May 18, 2016 | openfda |
| Atezolizumab | US FDA | Lung Non-Squamous Non-Small Cell Carcinoma | in combination with bevacizumab, paclitaxel, and carboplatin, for the first-line treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations. | approved | May 18, 2016 | openfda |
| Atezolizumab | US FDA | Lung Non-Small Cell Carcinoma | for the treatment of adult patients with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for NSCLC harboring these aberrations prior to receiving TECENTRIQ. | approved | May 18, 2016 | openfda |
| Atezolizumab | US FDA | Lung Small Cell Carcinoma | Small Cell Lung Cancer (SCLC) in combination with carboplatin and etoposide, for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). | approved | May 18, 2016 | openfda |
| Atezolizumab | US FDA | Lung Non-Small Cell Carcinoma | Non-Small Cell Lung Cancer (NSCLC) as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage II to IIIA NSCLC whose tumors have PD-L1 expression on ≥ 1% of tumor cells, as determined by an FDA-authorized test. | approved | May 18, 2016 | openfda |
| Atezolizumab | US FDA | Hepatocellular Carcinoma | Hepatocellular Carcinoma (HCC) in combination with bevacizumab for the treatment of adult patients with unresectable or metastatic HCC who have not received prior systemic therapy. | approved | May 18, 2016 | openfda |
| Atezolizumab | US FDA | Alveolar Soft Part Sarcoma | Alveolar Soft Part Sarcoma (ASPS) for the treatment of adult and pediatric patients 2 years of age and older with unresectable or metastatic ASPS. | approved | May 18, 2016 | openfda |
| Atezolizumab | US FDA | Lung Small Cell Carcinoma | in combination with lurbinectedin, for the maintenance treatment of adult patients with ES-SCLC whose disease has not progressed after first-line induction therapy with TECENTRIQ or atezolizumab and hyaluronidase-tqjs, carboplatin and etoposide. | approved | May 18, 2016 | openfda |
| Atezolizumab | US FDA | Malignant Bladder Neoplasm | Muscle Invasive Bladder Cancer (MIBC) as adjuvant treatment of adult patients with MIBC after cystectomy who have circulating tumor DNA molecular residual disease (ctDNA MRD) as determined by an FDA-authorized test. | approved | May 18, 2016 | openfda |
| Avelumab | US FDA | Urothelial Carcinoma | Urothelial Carcinoma (UC) Maintenance treatment of patients with locally advanced or metastatic UC that has not progressed with first-line platinum-containing chemotherapy. | approved | Mar 23, 2017 | openfda |
| Avelumab | US FDA | Renal Cell Carcinoma | Renal Cell Carcinoma (RCC) First-line treatment, in combination with axitinib, of patients with advanced RCC. | approved | Mar 23, 2017 | openfda |
| Avelumab | US FDA | Merkel Cell Carcinoma | Merkel Cell Carcinoma (MCC) Adults and pediatric patients 12 years and older with metastatic MCC. | approved | Mar 23, 2017 | openfda |
| Axitinib | US FDA | Renal Cell Carcinoma | as a single agent, for the treatment of advanced renal cell carcinoma (RCC) after failure of one prior systemic therapy. | approved | Jan 27, 2012 | openfda |
| Axitinib | US FDA | Renal Cell Carcinoma | in combination with avelumab, for the first-line treatment of patients with advanced renal cell carcinoma (RCC). | approved | Jan 27, 2012 | openfda |
| Azacitidine | US FDA | Acute Myeloid Leukemia | ONUREG is indicated for continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy. ONUREG is a nucleoside metabolic inhibitor indicated for continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy ( 1 ). | approved | Sep 1, 2020 | openfda |
| Azacitidine | US FDA | Juvenile Myelomonocytic Leukemia | Pediatric patients aged 1 month and older with newly diagnosed Juvenile Myelomonocytic Leukemia (JMML). | approved | May 19, 2004 | openfda |
| Belantamab Mafodotin | US FDA | Multiple Myeloma | BLENREP is indicated in combination with bortezomib and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent. BLENREP, a B‑cell maturation antigen (BCMA)‑directed antibody and microtubule inhibitor conjugate, is indicated in combination with bortezomib and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent. ( 1 ) | approved | Oct 23, 2025 | openfda |
| Belinostat | US FDA | Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma | Beleodaq is indicated for the treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on tumor response rate and duration of response [ see Clinical Studies ( 14 )]. An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial. Beleodaq is a histone deacetylase inhibitor indicated for the treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on tumor response rate and duration of response. An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial.( 1 )accelerated | approved | Jul 3, 2014 | openfda |
| Belzutifan | US FDA | Clear Cell Renal Cell Carcinoma | as monotherapy, for treatment of adult patients with advanced ccRCC following a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI). | approved | Aug 13, 2021 | openfda |
| Belzutifan | US FDA | Clear Cell Renal Cell Carcinoma | Renal Cell Carcinoma with a Clear Cell Component (ccRCC) in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, for the adjuvant treatment of adult patients with ccRCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. | approved | Aug 13, 2021 | openfda |