| Docetaxel | US FDA | Lung Non-Small Cell Carcinoma | Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC | approved | May 3, 2011 | openfda |
| Docetaxel | US FDA | Lung Non-Small Cell Carcinoma | Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC | approved | Mar 8, 2011 | openfda |
| Docetaxel | US FDA | Castration-Resistant Prostate Carcinoma | Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer | approved | Mar 8, 2011 | openfda |
| Docetaxel | US FDA | Gastric Adenocarcinoma | Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction | approved | Mar 8, 2011 | openfda |
| Docetaxel | US FDA | Head and Neck Squamous Cell Carcinoma | Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN | approved | Mar 8, 2011 | openfda |
| Docetaxel | US FDA | Lung Non-Small Cell Carcinoma | Non-small Cell Lung Cancer (NSCLC) : single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC | approved | May 14, 1996 | openfda |
| Docetaxel | US FDA | Castration-Resistant Prostate Carcinoma | Castration-Resistant Prostate Cancer (CRPC) : with prednisone in metastatic castration-resistant prostate cancer | approved | May 14, 1996 | openfda |
| Docetaxel | US FDA | Gastric Adenocarcinoma | Gastric Adenocarcinoma (GC) : with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction | approved | May 14, 1996 | openfda |
| Docetaxel | US FDA | Head and Neck Squamous Cell Carcinoma | Squamous Cell Carcinoma of the Head and Neck (SCCHN) : with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN | approved | May 14, 1996 | openfda |
| Dostarlimab | US FDA | Tumor-agnostic | as a single agent for the treatment of adult patients with mismatch repair deficient (dMMR) recurrent or advanced EC, as determined by an FDA-approved test, that has progressed on or following prior treatment with a platinum-containing regimen in any setting and are not candidates for curative surgery or radiation. • Mismatch Repair Deficient Recurrent or Advanced Solid Tumors • as a single agent for the treatment of adult patients with dMMR recurrent or advanced solid tumors, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options. 1 • 1 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 a confirmatory trial(s).accelerated | approved | Apr 22, 2021 | openfda |
| Durvalumab | US FDA | Lung Small Cell Carcinoma | as a single agent, for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. | approved | May 1, 2017 | openfda |
| Durvalumab | US FDA | Gastroesophageal Junction Adenocarcinoma | in combination with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) chemotherapy as neoadjuvant and adjuvant treatment, followed by single agent IMFINZI, for the treatment of adult patients with resectable gastric or gastroesophageal junction adenocarcinoma (GC/GEJC). | approved | May 1, 2017 | openfda |
| Durvalumab | US FDA | Hepatocellular Carcinoma | in combination with tremelimumab-actl, for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC). | approved | May 1, 2017 | openfda |
| Durvalumab | US FDA | Non-Muscle Invasive Bladder Carcinoma | in combination with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-naive, high-risk non-muscle-invasive bladder cancer (NMIBC). | approved | May 1, 2017 | openfda |
| Durvalumab | US FDA | Lung Non-Small Cell Carcinoma | as a single agent, for the treatment of adult patients with unresectable, Stage III NSCLC whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. | approved | May 1, 2017 | openfda |
| Durvalumab | US FDA | Lung Non-Small Cell Carcinoma | in combination with tremelimumab-actl and platinum-based chemotherapy, for the treatment of adult patients with metastatic NSCLC with no sensitizing EGFR mutations or ALK genomic tumor aberrations. | approved | May 1, 2017 | openfda |
| 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 |
| Encorafenib | US FDA | Lung Non-Small Cell Carcinoma | Non-Small Cell Lung Cancer (NSCLC) • in combination with binimetinib, for the treatment of adult patients with metastatic non–small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-authorized test. | approved | Jun 27, 2018 | 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 | Lung Non-Small Cell Carcinoma | Adult patients with ROS1- positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. | 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 | Oct 20, 2023 | openfda |
| Entrectinib | US FDA | Lung Non-Small Cell Carcinoma | Adult patients with ROS1- positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. | approved | Aug 15, 2019 | 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 |
| Enzalutamide | EU EMA | Castration-Resistant Prostate Carcinoma | Enzalutamide Viatris is indicated:• as monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high-risk biochemical recurrent (BCR) non-metastatic hormone-sensitive prostate cancer (nmHSPC) who are unsuitable for salvage-radiotherapy (see section 5.1);• in combination with androgen deprivation therapy for the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) (see section 5.1); • for the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC) (see section 5.1);• for the treatment of adult men with metastatic CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1);• for the treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy. | approved | Aug 22, 2024 | ema |
| Enzalutamide | EU EMA | Castration-Resistant Prostate Carcinoma | Xtandi is indicated for: as monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high risk biochemical recurrent (BCR) non-metastatic hormone sensitive prostate cancer (nmHSPC) who are unsuitable for salvage radiotherapy (see section 5.1). the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (see section 5.1). the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC) (see section 5.1). the treatment of adult men with metastatic CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1). the treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy. | approved | Jun 21, 2013 | ema |
| Enzalutamide | US FDA | Castration-Resistant Prostate Carcinoma | castration-resistant prostate cancer (CRPC) | approved | Aug 4, 2020 | openfda |
| Enzalutamide | US FDA | Castration-Resistant Prostate Carcinoma | castration-resistant prostate cancer. ( 1 ) | approved | Aug 4, 2020 | openfda |
| Enzalutamide | US FDA | Nonmetastatic Castration-Sensitive Prostate Carcinoma | non‑metastatic castration‑sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR) XTANDI is an androgen receptor inhibitor indicated for the treatment of patients with: | approved | Aug 4, 2020 | openfda |
| Enzalutamide | US FDA | Castration-Resistant Prostate Carcinoma | castration-resistant prostate cancer. ( 1 ) | approved | Aug 31, 2012 | openfda |
| Enzalutamide | US FDA | Castration-Resistant Prostate Carcinoma | castration-resistant prostate cancer (CRPC) | approved | Aug 31, 2012 | openfda |
| Enzalutamide | US FDA | Nonmetastatic Castration-Sensitive Prostate Carcinoma | non‑metastatic castration‑sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR) XTANDI is an androgen receptor inhibitor indicated for the treatment of patients with: | approved | Aug 31, 2012 | openfda |
| Erdafitinib | EU EMA | Urothelial Carcinoma | Balversa as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC), harbouring susceptible FGFR3 genetic alterations who have previously received at least one line of therapy containing a PD-1 or PD-L1 inhibitor in the unresectable or metastatic treatment setting (see section 5.1). | approved | Aug 22, 2024 | ema |
| Erdafitinib | US FDA | Urothelial Carcinoma | BALVERSA is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy. Select patients for therapy based on an FDA-approved companion diagnostic for BALVERSA [see Dosage and Administration (2.1) and Clinical Studies (14.1) ] . BALVERSA is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy. Select patients for therapy based on an FDA-approved companion diagnostic for BALVERSA. ( 1 , 2.1 ) Limitations of Use BALVERSA is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy. ( 1 , 14.1 ) Limitations of Use BALVERSA is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy [see Clinical Studies (14.1) ] . | approved | Apr 12, 2019 | openfda |
| Erlotinib | US FDA | Lung Non-Small Cell Carcinoma | The 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 receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen. | approved | Nov 9, 2020 | openfda |
| Erlotinib | US FDA | Lung Non-Small Cell Carcinoma | Limitations of Use: Safety and efficacy of erlotinib tablets have not been established in patients with NSCLC whose tumors have other EGFR mutations. | approved | Nov 9, 2020 | openfda |
| Erlotinib | US FDA | Lung Non-Small Cell Carcinoma | Limitations of Use: Safety and efficacy of erlotinib tablets have not been established in patients with NSCLC whose tumors have other EGFR mutations. | approved | Aug 28, 2015 | openfda |
| Erlotinib | US FDA | Lung Non-Small Cell Carcinoma | The 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 receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen. | approved | Aug 28, 2015 | openfda |
| Erlotinib Hydrochloride | US FDA | Lung Non-Small Cell Carcinoma | Limitations of Use: Safety and efficacy of erlotinib tablets have not been established in patients with NSCLC whose tumors have other EGFR mutations. | approved | Nov 5, 2019 | openfda |
| Erlotinib Hydrochloride | US FDA | Lung Non-Small Cell Carcinoma | The 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 receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen | approved | Nov 5, 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 |
| Flutamide | US FDA | Prostate Carcinoma | Eulexin ® capsules are indicated for use in combination with LHRH-agonists for the management of locally confined Stage B 2 -C and Stage D 2 metastatic carcinoma of the prostate. Stage B 2 -C Prostatic Carcinoma Treatment with Eulexin ® capsules and the goserelin acetate implant should start eight weeks prior to initiating radiation therapy and continue during radiation therapy. Stage D 2 Metastatic Carcinoma To achieve benefit from treatment, Eulexin ® capsules should be initiated with the LHRH-agonist and continued until progression. | approved | Sep 18, 2001 | openfda |