| Ivosidenib | US FDA | Cholangiocarcinoma | . Locally Advanced or Metastatic Cholangiocarcinoma For the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma who have been previously treated | approved | Jul 20, 2018 | openfda |
| Larotrectinib | US FDA | Tumor-agnostic | VITRAKVI is indicated for the treatment of adult and pediatric patients with solid tumors that: have a neurotrophic receptor tyrosine kinase ( NTRK ) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment. Select patients for therapy based on an FDA-approved test [see Dosage and Administration (2.1) ]. VITRAKVI is a kinase inhibitor indicated for the treatment of adult and pediatric patients with solid tumors that: have a neurotrophic receptor tyrosine kinase ( NTRK ) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment. Select patients for therapy based on an FDA-approved test. ( 1 , 2.1 ) | approved | Nov 26, 2018 | openfda |
| Larotrectinib | US FDA | Tumor-agnostic | VITRAKVI is indicated for the treatment of adult and pediatric patients with solid tumors that: have a neurotrophic receptor tyrosine kinase ( NTRK ) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment. Select patients for therapy based on an FDA-approved test [see Dosage and Administration (2.1) ]. VITRAKVI is a kinase inhibitor indicated for the treatment of adult and pediatric patients with solid tumors that: have a neurotrophic receptor tyrosine kinase ( NTRK ) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment. Select patients for therapy based on an FDA-approved test. ( 1 , 2.1 ) | approved | Nov 26, 2018 | openfda |
| Lazertinib | US FDA | Lung Non-Small Cell Carcinoma | LAZCLUZE, in combination with amivantamab, 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 (2.1) ] . LAZCLUZE is a kinase inhibitor indicated in combination with amivantamab 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. ( 1 ) | approved | Aug 19, 2024 | openfda |
| Lenvatinib | US FDA | Renal Cell Carcinoma | In combination with everolimus, for the treatment of adult patients with advanced renal cell carcinoma (RCC) following one prior anti-angiogenic therapy. | approved | Feb 13, 2015 | openfda |
| Lenvatinib | US FDA | Renal Cell Carcinoma | Renal Cell Carcinoma (RCC) In combination with pembrolizumab, for the first line treatment of adult patients with advanced renal cell carcinoma (RCC). | approved | Feb 13, 2015 | openfda |
| Lenvatinib | US FDA | Endometrial Carcinoma | Endometrial Carcinoma (EC) In combination with pembrolizumab, for the treatment of patients with advanced endometrial carcinoma (EC) that is mismatch repair proficient (pMMR) or not microsatellite instability-high (MSI-H), as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation. | approved | Feb 13, 2015 | openfda |
| Lenvatinib | US FDA | Hepatocellular Carcinoma | Hepatocellular Carcinoma (HCC) For the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). | approved | Feb 13, 2015 | openfda |
| Lurbinectedin | US FDA | Lung Small Cell Carcinoma | in combination with atezolizumab or atezolizumab and hyaluronidase-tqjs, for the maintenance treatment of adult patients with extensive-stage small cell lung cancer whose disease has not progressed after first-line induction therapy with atezolizumab or atezolizumab and hyaluronidase-tqjs, carboplatin and etoposide. | approved | Jun 15, 2020 | openfda |
| Lurbinectedin | US FDA | Lung Small Cell Carcinoma | For the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. | approved | Jun 15, 2020 | openfda |
| Margetuximab | US FDA | HER2-Positive Breast Carcinoma | MARGENZA is indicated, in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease [see Dosage and Administration (2.1) and Clinical Studies (14.1) ]. MARGENZA is a HER2/neu receptor antagonist indicated, in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. ( 1 , 2.1 , 14.1 ) | approved | Dec 16, 2020 | openfda |
| Megestrol | US FDA | Breast Carcinoma | Megestrol acetate tablets are indicated for the palliative treatment of advanced carcinoma of the breast or endometrium (ie, recurrent, inoperable, or metastatic disease). It should not be used in lieu of currently accepted procedures such as surgery, radiation, or chemotherapy. | approved | Aug 8, 1988 | openfda |
| Methotrexate | US FDA | Head and Neck Squamous Cell Carcinoma | o Treatment of adults with squamous cell carcinoma of the head and neck as a single agent. | approved | Aug 10, 1959 | openfda |
| Mitomycin | US FDA | Non-Muscle Invasive Bladder Carcinoma | ZUSDURI™ is indicated for the treatment of adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). ZUSDURI is an alkylating drug indicated for the treatment of adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). ( 1 ) | approved | Jun 12, 2025 | openfda |
| Mitotane | US FDA | Adrenal Cortical Carcinoma | LYSODREN is indicated for the treatment of patients with inoperable, functional or nonfunctional, adrenocortical carcinoma (ACC). LYSODREN is an adrenal cytotoxic agent indicated for the treatment of patients with inoperable, functional or nonfunctional, adrenocortical carcinoma (ACC). ( 1 ) | approved | Jul 8, 1970 | openfda |
| Neratinib | US FDA | HER2-Positive Breast Carcinoma | As a single agent, for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer, to follow adjuvant trastuzumab-based therapy. | approved | Jul 17, 2017 | openfda |
| Neratinib | US FDA | HER2-Positive Breast Carcinoma | In combination with capecitabine, for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting. | approved | Jul 17, 2017 | openfda |
| Nivolumab | US FDA | Renal Cell Carcinoma | Renal Cell Carcinoma (RCC) • adult patients with intermediate or poor risk advanced renal cell carcinoma, as a first-line treatment in combination with ipilimumab. | approved | Dec 22, 2014 | openfda |
| Nivolumab | US FDA | Lung Non-Small Cell Carcinoma | Non-Small Cell Lung Cancer (NSCLC) • adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer in the neoadjuvant setting, in combination with platinum-doublet chemotherapy. | approved | Dec 22, 2014 | openfda |
| Nivolumab | US FDA | Lung Non-Small Cell Carcinoma | adult patients with metastatic non-small cell lung cancer expressing PD‑L1 (≥1%) as determined by an FDA-authorized test, with no EGFR or ALK genomic tumor aberrations, as first-line treatment in combination with ipilimumab. | approved | Dec 22, 2014 | openfda |
| Nivolumab | US FDA | Lung Non-Small Cell Carcinoma | adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer and no known EGFR mutations or ALK rearrangements, for neoadjuvant treatment, in combination with platinum-doublet chemotherapy, followed by single-agent OPDIVO as adjuvant treatment after surgery. | approved | Dec 22, 2014 | openfda |
| Nivolumab | US FDA | Esophageal Squamous Cell Carcinoma | adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma as first-line treatment in combination with ipilimumab whose tumors express PD-L1 (≥1). | approved | Dec 22, 2014 | openfda |
| Nivolumab | US FDA | Esophageal Squamous Cell Carcinoma | adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma as first-line treatment in combination with fluoropyrimidine- and platinum‑containing chemotherapy whose tumors express PD-L1 (≥1). | approved | Dec 22, 2014 | openfda |
| Nivolumab | US FDA | Hepatocellular Carcinoma | Hepatocellular Carcinoma (HCC) • adult patients with unresectable or metastatic hepatocellular carcinoma (HCC), as a first-line treatment in combination with ipilimumab. | approved | Dec 22, 2014 | openfda |
| Nivolumab | US FDA | Urothelial Carcinoma | adult patients with unresectable or metastatic urothelial carcinoma, as first-line treatment in combination with cisplatin and gemcitabine. | approved | Dec 22, 2014 | openfda |
| Nivolumab | US FDA | Urothelial Carcinoma | Urothelial Carcinoma • adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC. | approved | Dec 22, 2014 | openfda |
| Nivolumab | US FDA | Renal Cell Carcinoma | adult patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy. | approved | Dec 22, 2014 | openfda |
| Nivolumab | US FDA | Esophageal Squamous Cell Carcinoma | adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy. | approved | Dec 22, 2014 | openfda |
| Nivolumab | US FDA | Lung Non-Small Cell Carcinoma | adult patients with 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 FDA-approved therapy for these aberrations prior to receiving OPDIVO. | approved | Dec 22, 2014 | openfda |
| Nivolumab | US FDA | Renal Cell Carcinoma | adult patients with advanced renal cell carcinoma, as a first-line treatment in combination with cabozantinib. | approved | Dec 22, 2014 | openfda |
| Nivolumab | US FDA | dMMR Colorectal Carcinoma | Colorectal Cancer • adult and pediatric (12 years and older) patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) in combination with ipilimumab. | approved | Dec 22, 2014 | openfda |
| Nivolumab | US FDA | Urothelial Carcinoma | adult patients with locally advanced or metastatic urothelial carcinoma who: • have disease progression during or following platinum-containing chemotherapy. • have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. | approved | Dec 22, 2014 | openfda |
| Nivolumab | US FDA | Head and Neck Squamous Cell Carcinoma | autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin, or • 3 or more lines of systemic therapy that includes autologous HSCT. Squamous Cell Carcinoma of the Head and Neck (SCCHN) • adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after a platinum-based therapy. | approved | Dec 22, 2014 | openfda |
| Nivolumab | US FDA | Lung Non-Small Cell Carcinoma | adult patients with metastatic or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations as first-line treatment, in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy. | approved | Dec 22, 2014 | openfda |
| Nogapendekin Alfa Inbakicept | US FDA | Non-Muscle Invasive Bladder Carcinoma | ANKTIVA in combination with Bacillus Calmette-Guérin (BCG) is indicated for the treatment of adult patients with BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. ANKTIVA is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. ( 1 ) | approved | Apr 22, 2024 | openfda |
| Olaparib | US FDA | Castration-Resistant Prostate Carcinoma | Prostate cancer • for the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. | approved | Aug 17, 2017 | openfda |
| Olaparib | US FDA | Hormone Receptor-Positive Breast Carcinoma | for the treatment of adult patients with deleterious or suspected deleterious gBRCA m, HER2-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. | approved | Aug 17, 2017 | openfda |
| Olaparib | US FDA | Pancreatic Adenocarcinoma | Pancreatic cancer • for the maintenance treatment of adult patients with deleterious or suspected deleterious gBRCA m metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. | approved | Aug 17, 2017 | openfda |
| Olaparib | US FDA | Castration-Resistant Prostate Carcinoma | in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA -mutated ( BRCA m) metastatic castration-resistant prostate cancer (mCRPC). Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. | approved | Aug 17, 2017 | openfda |
| Osimertinib | US FDA | Lung Non-Small Cell Carcinoma | the treatment of adult patients with locally advanced, unresectable (stage III) NSCLC whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. | approved | Nov 13, 2015 | openfda |
| Osimertinib | US FDA | Lung Non-Small Cell Carcinoma | the treatment of adult patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR TKI therapy. | approved | Nov 13, 2015 | openfda |
| Osimertinib | US FDA | Lung Non-Small Cell Carcinoma | the first-line treatment of adult patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. | approved | Nov 13, 2015 | openfda |
| Osimertinib | US FDA | Lung Non-Small Cell Carcinoma | adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. | approved | Nov 13, 2015 | openfda |
| Osimertinib | US FDA | Lung Non-Small Cell Carcinoma | in combination with pemetrexed and platinum-based chemotherapy, the first-line treatment of adult patients with locally advanced or metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. | approved | Nov 13, 2015 | openfda |
| Osimertinib Mesylate | US FDA | Lung Non-Small Cell Carcinoma | the treatment of adult patients with locally advanced, unresectable (stage III) NSCLC whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. | approved | Nov 13, 2015 | openfda |
| Osimertinib Mesylate | US FDA | Lung Non-Small Cell Carcinoma | the treatment of adult patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR TKI therapy. | approved | Nov 13, 2015 | openfda |
| Osimertinib Mesylate | US FDA | Lung Non-Small Cell Carcinoma | in combination with pemetrexed and platinum-based chemotherapy, the first-line treatment of adult patients with locally advanced or metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. | approved | Nov 13, 2015 | openfda |
| Osimertinib Mesylate | US FDA | Lung Non-Small Cell Carcinoma | the first-line treatment of adult patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. | approved | Nov 13, 2015 | openfda |
| Osimertinib Mesylate | US FDA | Lung Non-Small Cell Carcinoma | adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. | approved | Nov 13, 2015 | openfda |
| Paclitaxel | US FDA | Pancreatic Adenocarcinoma | Metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine. | approved | May 11, 2023 | openfda |