| Futibatinib | EU EMA | Cholangiocarcinoma | Lytgobi monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.conditional | approved | Jul 4, 2023 | ema |
| Futibatinib | US FDA | Intrahepatic Cholangiocarcinoma | LYTGOBI is indicated for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements [see Dosage and Administration (2.1) ] . This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14.1) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). LYTGOBI is a kinase inhibitor indicated for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements. ( 1 , 2.1 ) This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1 )accelerated | approved | Sep 30, 2022 | openfda |
| Gefitinib | EU EMA | Lung Non-Small Cell Carcinoma | Gefitinib Mylan is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic non small cell lung cancer (NSCLC) with activating mutations of EGFR TK. | withdrawnsince Sep 27, 2024 | Sep 27, 2018 | ema |
| Gefitinib | EU EMA | Lung Non-Small Cell Carcinoma | Iressa is indicated for the treatment of adult patients with locally advanced or metastatic non-small-cell lung cancer with activating mutations of epidermal-growth-factor-receptor tyrosine kinase. | approved | Jun 24, 2009 | ema |
| Gefitinib | US FDA | Lung Non-Small Cell Carcinoma | IRESSA is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test [see Clinical Studies (14) ] . Limitation of Use: Safety and efficacy of IRESSA have not been established in patients with metastatic NSCLC whose tumors have EGFR mutations other than exon 19 deletions or exon 21 (L858R) substitution mutations [see Clinical Studies (14) ] . IRESSA is a tyrosine kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test. (1) Limitation of Use: Safety and efficacy of IRESSA have not been established in patients whose tumors have EGFR mutations other than exon 19 deletions or exon 21 (L858R) substitution mutations. (1) | approved | Jul 13, 2015 | openfda |
| Gemcitabine | US FDA | Non-Muscle Invasive Bladder Carcinoma | INLEXZO is indicated for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. INLEXZO is a nucleoside metabolic inhibitor-containing intravesical system, indicated for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. ( 1 ) | approved | Sep 9, 2025 | openfda |
| Gemcitabine | US FDA | Lung Non-Small Cell Carcinoma | in combination with cisplatin, for the treatment of non-small cell lung cancer. | approved | Jun 27, 2025 | openfda |
| Gemcitabine | US FDA | Lung Non-Small Cell Carcinoma | in combination with cisplatin for the treatment of non-small cell lung cancer. | approved | Aug 3, 2017 | openfda |
| Gemcitabine | US FDA | Lung Non-Small Cell Carcinoma | in combination with cisplatin for the treatment of non-small cell lung cancer. | approved | Aug 4, 2011 | openfda |
| Goserelin | US FDA | Prostate Carcinoma | Use in combination with flutamide for the management of locally confined carcinoma of the prostate | approved | Jan 11, 1996 | openfda |
| Goserelin | US FDA | Prostate Carcinoma | Use as palliative treatment of advanced carcinoma of the prostate | approved | Jan 11, 1996 | openfda |
| Goserelin | US FDA | Prostate Carcinoma | Palliative treatment of advanced carcinoma of the prostate | approved | Dec 29, 1989 | openfda |
| Goserelin | US FDA | Prostate Carcinoma | Use in combination with flutamide for the management of locally confined carcinoma of the prostate | approved | Dec 29, 1989 | openfda |
| Imiquimod | EU EMA | Superficial Basal Cell Carcinoma | Imiquimod cream is indicated for the topical treatment of : External genital and perianal warts (condylomata acuminata) in adults. Small superficial basal cell carcinomas (sBCCs) in adults. Clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses (AKs) on the face or scalp in immunocompetent adult patients when size or number of lesions limit the efficacy and/or acceptability of cryotherapy and other topical treatment options are contraindicated or less appropriate. | approved | Sep 18, 1998 | ema |
| 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 | Lung Non-Small Cell Carcinoma | Non-Small Cell Lung Cancer (NSCLC) • Treatment of 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 nivolumab. | approved | Mar 25, 2011 | openfda |
| Ipilimumab | US FDA | Lung Non-Small Cell Carcinoma | Treatment of 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 nivolumab and 2 cycles of platinum-doublet chemotherapy. | approved | Mar 25, 2011 | openfda |
| Ipilimumab | US FDA | dMMR Colorectal Carcinoma | Colorectal Cancer • Treatment of adults and pediatric patients 12 years and older with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) as determined by an FDA-authorized test in combination with nivolumab. | approved | Mar 25, 2011 | 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 | 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 |
| Irinotecan | US FDA | Colon Carcinoma | CAMPTOSAR is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy. CAMPTOSAR is a topoisomerase inhibitor indicated for: | approved | Jun 14, 1996 | openfda |
| Irinotecan | US FDA | Colon Carcinoma | CAMPTOSAR is indicated as a component of first-line therapy in combination with 5-fluorouracil (5-FU) and leucovorin (LV) for patients with metastatic carcinoma of the colon or rectum. | approved | Jun 14, 1996 | openfda |
| Irinotecan | US FDA | Colon Carcinoma | Patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy. ( 1 ) | approved | Jun 14, 1996 | openfda |
| Irinotecan | US FDA | Colon Carcinoma | First-line therapy in combination with 5-fluorouracil and leucovorin for patients with metastatic carcinoma of the colon or rectum. ( 1 ) | approved | Jun 14, 1996 | openfda |
| 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 | 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 |
| Lazertinib | EU EMA | Lung Non-Small Cell Carcinoma | Lazcluze in combination with amivantamab is indicated for the first line treatment of adult patients with advanced non small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R substitution mutations. | approved | Jan 20, 2025 | ema |
| 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 | 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 | 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 |
| Lorlatinib | EU EMA | Lung Non-Small Cell Carcinoma | Lorviqua as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)?positive advanced non?small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor. Lorviqua as monotherapy is indicated for the treatment of adult patients with ALK?positive advanced NSCLC whose disease has progressed after: alectinib or ceritinib as the first ALK tyrosine kinase inhibitor (TKI) therapy; or crizotinib and at least one other ALK TKI. | approved | May 6, 2019 | ema |
| 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 | 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 | 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 |
| Nadofaragene Firadenovec | EU EMA | Non-Muscle Invasive Bladder Carcinoma | Adstiladrin is indicated as monotherapy for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumours.conditional | approved | May 28, 2026 | ema |
| Necitumumab | EU EMA | Lung Non-Small Cell Carcinoma | Portrazza in combination with gemcitabine and cisplatin chemotherapy is indicated for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) expressing squamous non-small cell lung cancer who have not received prior chemotherapy for this condition. | withdrawn | Feb 15, 2016 | ema |
| 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 |