Neoplasm of Uncertain Histogenesis — Drugs

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Drug	Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
Enfortumab Vedotin	US FDA	Malignant Bladder Neoplasm	in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, for the treatment of adult patients with muscle invasive bladder cancer (MIBC). ( 1 )	approved	Dec 18, 2019	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	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	US FDA	Castration-Resistant Prostate Carcinoma	castration-resistant prostate cancer. ( 1 )	approved	Aug 4, 2020	openfda
Enzalutamide	US FDA	Malignant Prostate Neoplasm	metastatic castration-sensitive prostate cancer (mCSPC)	approved	Aug 4, 2020	openfda
Enzalutamide	US FDA	Castration-Resistant Prostate Carcinoma	castration-resistant prostate cancer (CRPC)	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	Malignant Prostate Neoplasm	non‑metastatic castration‑sensitive prostate cancer with biochemical recurrence at high risk for metastasis. ( 1 )	approved	Aug 4, 2020	openfda
Enzalutamide	US FDA	Malignant Prostate Neoplasm	metastatic castration-sensitive prostate cancer. ( 1 )	approved	Aug 4, 2020	openfda
Enzalutamide	US FDA	Malignant Prostate Neoplasm	metastatic castration-sensitive prostate cancer (mCSPC)	approved	Aug 31, 2012	openfda
Enzalutamide	US FDA	Malignant Prostate Neoplasm	non‑metastatic castration‑sensitive prostate cancer with biochemical recurrence at high risk for metastasis. ( 1 )	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
Enzalutamide	US FDA	Castration-Resistant Prostate Carcinoma	castration-resistant prostate cancer (CRPC)	approved	Aug 31, 2012	openfda
Enzalutamide	US FDA	Castration-Resistant Prostate Carcinoma	castration-resistant prostate cancer. ( 1 )	approved	Aug 31, 2012	openfda
Enzalutamide	US FDA	Malignant Prostate Neoplasm	metastatic castration-sensitive prostate cancer. ( 1 )	approved	Aug 31, 2012	openfda
Epcoritamab	US FDA	Follicular Lymphoma	This indication is approved under accelerated approval based on 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). In combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL).accelerated	approved	May 19, 2023	openfda
Epirubicin	US FDA	Malignant Breast Neoplasm	ELLENCE is indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer [see Clinical Studies (14.1) ] . ELLENCE is an anthracycline topoisomerase inhibitor indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer ( 1 ).	approved	Sep 15, 1999	openfda
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
Eribulin	US FDA	Malignant Breast Neoplasm	Metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting.	approved	Nov 15, 2010	openfda
Eribulin	US FDA	Liposarcoma	Unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen.	approved	Nov 15, 2010	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	Malignant Pancreatic Neoplasm	First-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine.	approved	Nov 9, 2020	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	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	US FDA	Malignant Pancreatic Neoplasm	First-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine.	approved	Aug 28, 2015	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 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
Erlotinib Hydrochloride	US FDA	Malignant Pancreatic Neoplasm	First-line treatment of patients with locally advanced, unrespectable or metastatic pancreatic cancer, in combination with gemcitabine.	approved	Nov 5, 2019	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
Etoposide	US FDA	Lung Small Cell Carcinoma	Small cell lung cancer	approved	Feb 13, 2026	openfda
Etoposide	US FDA	Malignant Testicular Neoplasm	Refractory testicular 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	US FDA	Primitive Neuroectodermal Tumor	Adults with progressive neuroendocrine tumors of pancreatic origin (PNET) and adults with progressive, well-differentiated, non-functional neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin that are unresectable, locally advanced or metastatic. Limitations of Use: AFINITOR is not indicated for the treatment of patients with functional carcinoid tumors.	approved	Aug 29, 2012	openfda
Everolimus	US FDA	Malignant Breast Neoplasm	Postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole.	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	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
Everolimus	US FDA	Malignant Breast Neoplasm	Postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole.	approved	Mar 30, 2009	openfda
Everolimus	US FDA	Primitive Neuroectodermal Tumor	Adults with progressive neuroendocrine tumors of pancreatic origin (PNET) and adults with progressive, well-differentiated, non-functional neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin that are unresectable, locally advanced or metastatic. Limitations of Use: AFINITOR is not indicated for the treatment of patients with functional carcinoid tumors.	approved	Mar 30, 2009	openfda
Exemestane	US FDA	Malignant Breast Neoplasm	adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received two to three years of tamoxifen and are switched to EXEMESTANE for completion of a total of five consecutive years of adjuvant hormonal therapy ( 14.1 ).	approved	Oct 21, 1999	openfda
Exemestane	US FDA	Malignant Breast Neoplasm	treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy ( 14.2 ).	approved	Oct 21, 1999	openfda
Filgrastim	US FDA	Acute Myeloid Leukemia	Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML).	approved	Feb 25, 2022	openfda
Filgrastim	US FDA	Acute Myeloid Leukemia	Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML)	approved	Feb 20, 1991	openfda
Fludarabine	US FDA	Chronic Lymphocytic Leukemia	Fludarabine Phosphate Injection is a nucleotide metabolic inhibitor indicated for: The treatment of adult patients with B-cell chronic lymphocytic leukemia (CLL) who have not responded to or whose disease has progressed during treatment with at least one standard alkylating-agent containing regimen. Benefit in treatment-naïve or non-refractory CLL patients is not established.	approved	Apr 28, 2004	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	Pancreatic Adenocarcinoma	Pancreatic Adenocarcinoma	approved	Feb 20, 2026	openfda
Fluorouracil	US FDA	Gastric Adenocarcinoma	Gastric Adenocarcinoma	approved	Feb 20, 2026	openfda
Fluorouracil	US FDA	Breast Adenocarcinoma	Adenocarcinoma of the Breast	approved	Feb 20, 2026	openfda

Drug

Jurisdiction · authority

Cancer

Indication

Status

Approval date

Source

Enfortumab Vedotin

US FDA

Malignant Bladder Neoplasm

in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, for the treatment of adult patients with muscle invasive bladder cancer (MIBC). ( 1 )

approved

Dec 18, 2019

Therapy	Evidence items (count)	Sensitivity / response	Resistance
Cetuximab	401	91	309
Dasatinib	307	174	133
Erlotinib	266	172	94
Crizotinib	255	135	120
Vemurafenib	252	141	110
Gefitinib	185	142	43
Imatinib	165	73	92
Trametinib	149	123	26
Afatinib	129	120	9
Panitumumab	127	34	93
Trastuzumab	127	90	37
Dabrafenib	105	72	33
Olaparib	105

Approvals by jurisdiction

Therapies appearing in curated evidence