| Pemetrexed | US FDA | Lung Non-Small Cell Carcinoma | Limitations of Use: Pemetrexed Injection is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer. | approved | Aug 21, 2020 | openfda |
| Pemetrexed | US FDA | Lung Non-Squamous Non-Small Cell Carcinoma | as a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy. | approved | Aug 21, 2020 | openfda |
| Pemetrexed | US FDA | Lung Non-Squamous Non-Small Cell Carcinoma | as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. | approved | Aug 21, 2020 | openfda |
| Pemetrexed | US FDA | Lung Non-Squamous Non-Small Cell Carcinoma | in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous NSCLC, with no EGFR or ALK genomic tumor aberrations. | approved | Feb 8, 2020 | openfda |
| Pemetrexed | US FDA | Lung Non-Small Cell Carcinoma | Limitations of Use : PEMFEXY is not indicated for the treatment of patients with squamous cell non-small cell lung cancer. | approved | Feb 8, 2020 | openfda |
| Pemetrexed | US FDA | Lung Non-Squamous Non-Small Cell Carcinoma | in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic non-squamous, non-small cell lung cancer (NSCLC). | approved | Feb 8, 2020 | openfda |
| Pemetrexed | US FDA | Lung Non-Squamous Non-Small Cell Carcinoma | as a single agent for the maintenance treatment of patients with locally advanced or metastatic non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. | approved | Feb 8, 2020 | openfda |
| Pemetrexed | US FDA | Lung Non-Squamous Non-Small Cell Carcinoma | as a single agent for the treatment of patients with recurrent, metastatic non-squamous NSCLC after prior chemotherapy. | approved | Feb 8, 2020 | openfda |
| Pemetrexed | US FDA | Lung Non-Small Cell Carcinoma | Limitations of Use: ALIMTA is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer. | approved | Feb 4, 2004 | openfda |
| Pemetrexed | US FDA | Lung Non-Squamous Non-Small Cell Carcinoma | as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. | approved | Feb 4, 2004 | openfda |
| Pemetrexed | US FDA | Lung Non-Squamous Non-Small Cell Carcinoma | in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. | approved | Feb 4, 2004 | openfda |
| Pemetrexed | US FDA | Lung Non-Squamous Non-Small Cell Carcinoma | in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous NSCLC. | approved | Feb 4, 2004 | openfda |
| Pemetrexed | US FDA | Lung Non-Squamous Non-Small Cell Carcinoma | as a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy. | approved | Feb 4, 2004 | openfda |
| Pemigatinib | US FDA | Cholangiocarcinoma | Cholangiocarcinoma PEMAZYRE is indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test [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).accelerated | approved | Apr 17, 2020 | openfda |
| Pertuzumab | US FDA | Early Stage Breast Carcinoma | Use in combination with trastuzumab and chemotherapy as neoadjuvant treatment of adults with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer. | approved | Jun 8, 2012 | openfda |
| Porfimer | US FDA | Lung Non-Small Cell Carcinoma | Treatment of microinvasive endobronchial non-small-cell lung cancer (NSCLC) in patients for whom surgery and radiotherapy are not indicated Reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial NSCLC High-Grade Dysplasia in Barrett’s Esophagus | approved | Dec 27, 1995 | openfda |
| Pralsetinib | US FDA | Lung Non-Small Cell Carcinoma | Adult patients with metastatic rearranged during transfection (RET ) fusion-positive non-small cell lung cancer as detected by an FDA approved test (NSCLC). | approved | Sep 4, 2020 | openfda |
| Radium Ra-223 Dichloride | US FDA | Castration-Resistant Prostate Carcinoma | Xofigo is indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. Xofigo is an alpha particle-emitting radioactive therapeutic agent indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. ( 1 ) | approved | May 15, 2013 | openfda |
| Ramucirumab | US FDA | Lung Non-Small Cell Carcinoma | in combination with docetaxel, for treatment of adults with metastatic non-small cell lung cancer with disease 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 CYRAMZA. | approved | Apr 21, 2014 | openfda |
| Ramucirumab | US FDA | Hepatocellular Carcinoma | as a single agent, for the treatment of adults with hepatocellular carcinoma in patients who have an alpha fetoprotein of ≥400 ng/mL and have been treated with sorafenib. | approved | Apr 21, 2014 | openfda |
| Ramucirumab | US FDA | Lung Non-Small Cell Carcinoma | in combination with erlotinib, for first-line treatment of adults with metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations. | approved | Apr 21, 2014 | openfda |
| Regorafenib | US FDA | Hepatocellular Carcinoma | Hepatocellular carcinoma (HCC) who have been previously treated with sorafenib | approved | Sep 27, 2012 | openfda |
| Repotrectinib | US FDA | Tumor-agnostic | adult and pediatric patients 12 years of age and older with solid tumors that: • have a neurotrophic tyrosine receptor kinase ( NTRK ) gene fusion and • are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity. • have progressed following treatment or have no satisfactory alternative therapy. 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 the confirmatory trials.accelerated | approved | Nov 15, 2023 | openfda |
| Repotrectinib | US FDA | ROS1-Positive Lung Non-Small Cell Carcinoma | AUGTYRO is a kinase inhibitor indicated for the treatment of • adult patients with locally advanced or metastatic ROS1- positive non-small cell lung cancer (NSCLC). | approved | Nov 15, 2023 | openfda |
| Retifanlimab | US FDA | Merkel Cell Carcinoma | Merkel Cell Carcinoma (MCC) for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). | approved | Mar 22, 2023 | openfda |
| Rucaparib | US FDA | Castration-Resistant Prostate Carcinoma | Prostate cancer for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy. Select patients for therapy based on an FDA-approved companion diagnostic for RUBRACA. | approved | Dec 19, 2016 | openfda |
| Sacituzumab Govitecan | US FDA | Triple-Negative Breast Carcinoma | In combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph for the first-line treatment of adult patients with unresectable locally advanced or metastatic TNBC whose tumors express PD-L1 (CPS ≥ 10) as determined by an FDA-authorized test. | approved | Apr 22, 2020 | openfda |
| Sacituzumab Govitecan | US FDA | Triple-Negative Breast Carcinoma | Locally Advanced or Metastatic Triple-Negative Breast Cancer First Line As a single agent for the first-line treatment of adult patients with unresectable locally advanced or metastatic triple negative breast cancer (TNBC) who are not candidates for PD-1 or PD-L1 inhibitor-based therapy. | approved | Apr 22, 2020 | openfda |
| Selpercatinib | US FDA | Tumor-agnostic | Adult and pediatric patients 2 years of age and older with locally advanced or metastatic solid tumors with a RET gene fusion, as detected by an FDA-approved test, that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options | approved | Apr 10, 2024 | openfda |
| Selpercatinib | US FDA | Lung Non-Small Cell Carcinoma | Adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test | approved | Apr 10, 2024 | openfda |
| Selpercatinib | US FDA | Thyroid Gland Medullary Carcinoma | Adult and pediatric patients 2 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy | approved | Apr 10, 2024 | openfda |
| Selpercatinib | US FDA | Tumor-agnostic | Adult and pediatric patients 2 years of age and older with locally advanced or metastatic solid tumors with a RET gene fusion, as detected by an FDA-approved test, that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options | approved | May 8, 2020 | openfda |
| Selpercatinib | US FDA | Thyroid Gland Medullary Carcinoma | Adult and pediatric patients 2 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy | approved | May 8, 2020 | openfda |
| Selpercatinib | US FDA | Lung Non-Small Cell Carcinoma | Adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test | approved | May 8, 2020 | openfda |
| Sevabertinib | US FDA | Lung Non-Squamous Non-Small Cell Carcinoma | HYRNUO is indicated for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 ( ERBB2 ) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test [see Dosage and Administration (2.1) ] , and who have received a prior systemic therapy. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR) [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. HYRNUO is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 ( ERBB2 ) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy. ( 1 ) This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.accelerated | approved | Nov 19, 2025 | openfda |
| Sonidegib | US FDA | Basal Cell Carcinoma | ODOMZO (sonidegib) is indicated for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy. ODOMZO is a hedgehog pathway inhibitor indicated for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy. ( 1 ) | approved | Jul 24, 2015 | openfda |
| Sorafenib | US FDA | Renal Cell Carcinoma | Advanced renal cell carcinoma | approved | Dec 1, 2005 | openfda |
| Sorafenib | US FDA | Hepatocellular Carcinoma | NEXAVAR is a kinase inhibitor indicated for the treatment of • Unresectable hepatocellular carcinoma | approved | Dec 1, 2005 | openfda |
| Sorafenib | US FDA | Differentiated Thyroid Gland Carcinoma | Locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) refractory to radioactive iodine treatment | approved | Dec 1, 2005 | openfda |
| Sorafenib Tosylate | US FDA | Differentiated Thyroid Gland Carcinoma | Locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) refractory to radioactive iodine treatment | approved | Dec 1, 2005 | openfda |
| Sorafenib Tosylate | US FDA | Hepatocellular Carcinoma | NEXAVAR is a kinase inhibitor indicated for the treatment of • Unresectable hepatocellular carcinoma | approved | Dec 1, 2005 | openfda |
| Sorafenib Tosylate | US FDA | Renal Cell Carcinoma | Advanced renal cell carcinoma | approved | Dec 1, 2005 | openfda |
| Sotorasib | US FDA | Lung Non-Small Cell Carcinoma | KRAS G12C-mutated Locally Advanced or Metastatic 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 | May 28, 2021 | openfda |
| Sunitinib | US FDA | Renal Cell Carcinoma | treatment of adult patients with advanced renal cell carcinoma (RCC). | approved | Jan 26, 2006 | openfda |
| Talazoparib | US FDA | Castration-Resistant Prostate Carcinoma | HRR Gene-Mutated mCRPC • In combination with enzalutamide for the treatment of adult patients with HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC). | approved | Mar 7, 2024 | openfda |
| Talazoparib | US FDA | Castration-Resistant Prostate Carcinoma | HRR Gene-mutated Metastatic Castration-Resistant Prostate Cancer (mCRPC) • In combination with enzalutamide for the treatment of adult patients with HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC). | approved | Oct 16, 2018 | openfda |
| Taletrectinib | US FDA | ROS1-Positive Lung Non-Small Cell Carcinoma | IBTROZI ® (taletrectinib) is indicated for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC) [see Dosage and Administration ( 2.1 )] . IBTROZI is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC). ( 1 ) | approved | Jun 11, 2025 | openfda |
| Tarlatamab | US FDA | Lung Small Cell Carcinoma | IMDELLTRA is indicated for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. IMDELLTRA is a bispecific delta-like ligand 3 (DLL3)-directed CD3 T- cell engager indicated for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum - based chemotherapy. ( 1 ) | approved | May 16, 2024 | openfda |
| Temsirolimus | US FDA | Renal Cell Carcinoma | TORISEL is indicated for the treatment of advanced renal cell carcinoma. TORISEL ® is a kinase inhibitor indicated for the treatment of advanced renal cell carcinoma. ( 1 ) | approved | May 30, 2007 | openfda |
| Tepotinib | US FDA | Lung Non-Small Cell Carcinoma | TEPMETKO is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition ( MET ) exon 14 skipping alterations. TEPMETKO is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition ( MET ) exon 14 skipping alterations. ( 1 ) | approved | Feb 3, 2021 | openfda |