| Durvalumab | US FDA | Lung Small Cell Carcinoma | in combination with etoposide and either carboplatin or cisplatin, as first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). | approved | May 1, 2017 | openfda |
| Entrectinib | EU EMA | Tumor-agnosticLung Non-Small Cell Carcinoma | Rozlytrek as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with solid tumours expressing a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have not received a prior NTRK inhibitor who have no satisfactory treatment options. Rozlytrek as monotherapy is indicated for the treatment of adult patients with ROS1 positive, advanced non small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors.conditional | approved | Jul 31, 2020 | ema |
| Entrectinib | US FDA | Tumor-agnostic | Adult and pediatric patients older than 1 month of age with solid tumors that: have a neurotrophic tyrosine receptor kinase ( NTRK) gene fusion, as detected by an FDA-approved test without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.accelerated | approved | Oct 20, 2023 | openfda |
| Entrectinib | US FDA | Tumor-agnostic | Adult and pediatric patients older than 1 month of age with solid tumors that: have a neurotrophic tyrosine receptor kinase ( NTRK) gene fusion, as detected by an FDA-approved test without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.accelerated | approved | Aug 15, 2019 | openfda |
| Etoposide | US FDA | Lung Small Cell Carcinoma | Small cell lung cancer | approved | Feb 13, 2026 | openfda |
| Etoposide | US FDA | Lung Small Cell Carcinoma | Small cell lung cancer, in combination with cisplatin, as first-line treatment. | approved | May 17, 1996 | openfda |
| Etoposide | US FDA | Lung Small Cell Carcinoma | VePesid (etoposide) is indicated in the management of: Small Cell Lung Cancer— VePesid Capsules in combination with other approved chemotherapeutic agents as first line treatment in patients with small cell lung cancer. | approved | Dec 30, 1986 | openfda |
| Everolimus | EU EMA | Renal Cell Carcinoma | Hormone-receptor-positive advanced breast cancer Afinitor is indicated for the treatment of hormone-receptor-positive, HER2/neu-negative advanced breast cancer, in combination with exemestane, in post-menopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor. Neuroendocrine tumours of pancreatic origin Afinitor is indicated for the treatment of unresectable or metastatic, well or moderately differentiated neuroendocrine tumours of pancreatic origin in adults with progressive disease. Neuroendocrine tumours of gastrointestinal or lung origin Afinitor is indicated for the treatment of unresectable or metastatic, well-differentiated (Grade 1 or Grade 2) non-functional neuroendocrine tumours of gastrointestinal or lung origin in adults with progressive disease. Renal-cell carcinoma Afinitor is indicated for the treatment of patients with advanced renal-cell carcinoma, whose disease has progressed on or after treatment with VEGF-targeted therapy. | approved | Aug 2, 2009 | ema |
| Everolimus | US FDA | Renal Cell Carcinoma | Adults with advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib or sorafenib. | approved | Aug 29, 2012 | openfda |
| Everolimus | US FDA | Renal Cell Carcinoma | Adults with advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib or sorafenib. | approved | Mar 30, 2009 | openfda |
| Fluorouracil | US FDA | Breast Adenocarcinoma | Adenocarcinoma of the Breast | approved | Feb 20, 2026 | openfda |
| Fluorouracil | US FDA | Pancreatic Adenocarcinoma | Pancreatic Adenocarcinoma | approved | Feb 20, 2026 | openfda |
| Fluorouracil | US FDA | Colon Adenocarcinoma | FAVLYXA is a nucleoside metabolic inhibitor indicated for the treatment of patients with: Adenocarcinoma of the Colon and Rectum | approved | Feb 20, 2026 | openfda |
| Fluorouracil | US FDA | Gastric Adenocarcinoma | Gastric Adenocarcinoma | approved | Feb 20, 2026 | openfda |
| Ipilimumab | US FDA | Renal Cell Carcinoma | Renal Cell Carcinoma (RCC) • Treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma, as first-line treatment in combination with nivolumab. | approved | Mar 25, 2011 | openfda |
| Ipilimumab | US FDA | Esophageal Squamous Cell Carcinoma | Esophageal Cancer • Treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma, as first line treatment in combination with nivolumab whose tumors express PD-L1 (≥1). | approved | Mar 25, 2011 | openfda |
| Ipilimumab | US FDA | Hepatocellular Carcinoma | Hepatocellular Carcinoma • adult patients with unresectable or metastatic hepatocellular carcinoma (HCC) as first-line treatment in combination with nivolumab. | approved | Mar 25, 2011 | openfda |
| Irinotecan | EU EMA | Pancreatic Adenocarcinoma | ONIVYDE pegylated liposomal is indicated:- in combination with oxaliplatin, 5 fluorouracil (5 FU) and leucovorin (LV) for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas,- in combination with 5-FU and LV for the treatment of metastatic adenocarcinoma of the pancreas, in adult patients who have progressed following gemcitabine based therapy. | approved | Oct 14, 2016 | ema |
| Irinotecan | US FDA | Pancreatic Adenocarcinoma | ONIVYDE is indicated, in combination with oxaliplatin, fluorouracil and leucovorin for the first-line treatment of adult patients with metastatic pancreatic adenocarcinoma. ONIVYDE is indicated, in combination with fluorouracil and leucovorin, for the treatment of adult patients with metastatic pancreatic adenocarcinoma after disease progression following gemcitabine-based therapy. Limitations of Use: ONIVYDE is not indicated as a single agent for the treatment of patients with metastatic pancreatic adenocarcinoma. [see Clinical Studies (14) ] . ONIVYDE is a topoisomerase inhibitor indicated: in combination with oxaliplatin, fluorouracil and leucovorin, for the first-line treatment of adult patients with metastatic pancreatic adenocarcinoma, ( 1 ) in combination with fluorouracil and leucovorin, for the treatment of adult patients with metastatic pancreatic adenocarcinoma after disease progression following gemcitabine-based therapy. ( 1 ) Limitation of Use: ONIVYDE is not indicated as a single agent for the treatment of patients with metastatic pancreatic adenocarcinoma. ( 1 ) | approved | Oct 22, 2015 | openfda |
| Larotrectinib | EU EMA | Tumor-agnostic | Vitrakvi as monotherapy is indicated for the treatment of adult and paediatric patients with solid tumours that display a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion, who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have no satisfactory treatment options.conditional | approved | Sep 19, 2019 | ema |
| 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 |
| Lenvatinib | EU EMA | Renal Cell Carcinoma | Kisplyx is indicated for the treatment of adults with advanced renal cell carcinoma (RCC): in combination with pembrolizumab, as first-line treatment (see section 5.1). in combination with everolimus, following one prior vascular endothelial growth factor (VEGF)-targeted therapy.accelerated | approved | Aug 25, 2016 | ema |
| 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 |
| 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 |
| Lurbinectedin | EU EMA | Lung Small Cell Carcinoma | Zepzelca, in combination with atezolizumab, is indicated for the maintenance treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide. | approved | May 29, 2026 | ema |
| 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 |
| 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 |
| 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 |
| 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 |
| Mitotane | EU EMA | Adrenal Cortical Carcinoma | Symptomatic treatment of advanced (unresectable, metastatic or relapsed) adrenal cortical carcinoma. The effect of Lysodren on non-functional adrenal cortical carcinoma is not established. | approved | Apr 28, 2004 | ema |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | Renal Cell Carcinoma | adult patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy. | approved | Dec 22, 2014 | 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 | 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 |
| Paclitaxel | US FDA | Pancreatic Adenocarcinoma | Metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine. | approved | May 11, 2023 | openfda |
| Paclitaxel | US FDA | Pancreatic Adenocarcinoma | Metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine. | approved | Jul 27, 2022 | openfda |
| Paclitaxel | US FDA | Pancreatic Adenocarcinoma | Metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine. | approved | Jan 7, 2005 | openfda |
| Padeliporfin | EU EMA | Prostate Adenocarcinoma | Tookad is indicated as monotherapy for adult patients with previously untreated, unilateral, low risk, adenocarcinoma of the prostate with a life expectancy ? 10 years and: Clinical stage T1c or T2a; Gleason Score ? 6, based on high-resolution biopsy strategies; PSA ? 10 ng/mL; 3 positive cancer cores with a maximum cancer core length of 5 mm in any one core or 1-2 positive cancer cores with ? 50 % cancer involvement in any one core or a PSA density ? 0.15 ng/mL/cm³. | approved | Nov 10, 2017 | ema |
| Pazopanib | US FDA | Renal Cell Carcinoma | advanced renal cell carcinoma (RCC). | approved | Oct 19, 2009 | openfda |