Neoplasm by Site — Drugs

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Drug	Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
Datopotamab Deruxtecan	US FDA	Triple-Negative Breast Carcinoma	This indication is approved under accelerated approval based on objective 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 the confirmatory trial. adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy [see Clinical Studies (14.2) ] .accelerated	approved	Jan 17, 2025	openfda
Datopotamab Deruxtecan	US FDA	Lung Non-Small Cell Carcinoma with EGFR Mutation	adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy.	approved	Jan 17, 2025	openfda
Degarelix	US FDA	Malignant Prostate Neoplasm	FIRMAGON ® is indicated for treatment of patients with advanced prostate cancer. FIRMAGON is a GnRH receptor antagonist indicated for treatment of patients with advanced prostate cancer. ( 1 )	approved	Dec 24, 2008	openfda
Denosumab	US FDA	Malignant Breast Neoplasm	to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer	approved	Oct 29, 2025	openfda
Denosumab	US FDA	Malignant Prostate Neoplasm	to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer	approved	Oct 29, 2025	openfda
Denosumab	US FDA	Malignant Prostate Neoplasm	to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer	approved	Oct 29, 2025	openfda
Denosumab	US FDA	Malignant Breast Neoplasm	to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer	approved	Oct 29, 2025	openfda
Denosumab	US FDA	Multiple Myeloma	Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors.	approved	Oct 29, 2025	openfda
Denosumab	US FDA	Multiple Myeloma	Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors.	approved	Aug 29, 2025	openfda
Denosumab	US FDA	Malignant Breast Neoplasm	to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer	approved	Mar 25, 2025	openfda
Denosumab	US FDA	Malignant Prostate Neoplasm	to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer	approved	Mar 25, 2025	openfda
Denosumab	US FDA	Malignant Prostate Neoplasm	to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer	approved	Feb 13, 2025	openfda
Denosumab	US FDA	Malignant Breast Neoplasm	to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer	approved	Feb 13, 2025	openfda
Denosumab	US FDA	Malignant Breast Neoplasm	to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.	approved	Mar 5, 2024	openfda
Denosumab	US FDA	Malignant Prostate Neoplasm	to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer.	approved	Mar 5, 2024	openfda
Denosumab	US FDA	Malignant Breast Neoplasm	to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer	approved	Jun 1, 2010	openfda
Denosumab	US FDA	Malignant Prostate Neoplasm	to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer	approved	Jun 1, 2010	openfda
Dexamethasone	US FDA	Multiple Myeloma	HEMADY is indicated in combination with other anti-myeloma products for the treatment of adults with multiple myeloma (MM). HEMADY is a corticosteroid indicated in combination with other anti-myeloma products for the treatment of adults with multiple myeloma. (‎ 1 )	approved	Oct 3, 2019	openfda
Dexamethasone	US FDA	Conventional Osteosarcoma	The treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)	approved	Jun 17, 2009	openfda
Dinutuximab	US FDA	High Risk Neuroblastoma	Unituxin (dinutuximab) is indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy [see Clinical Studies (14) ] . Unituxin is a GD2-binding monoclonal antibody indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy. ( 1 )	approved	Mar 10, 2015	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	Oct 23, 2024	openfda
Docetaxel	US FDA	Malignant Breast Neoplasm	Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC	approved	Oct 23, 2024	openfda
Docetaxel	US FDA	Gastric Adenocarcinoma	Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction	approved	Oct 23, 2024	openfda
Docetaxel	US FDA	Castration-Resistant Prostate Carcinoma	Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer	approved	Oct 23, 2024	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	Oct 23, 2024	openfda
Docetaxel	US FDA	Castration-Resistant Prostate Carcinoma	Castration- Resistant Prostate Cancer (CRPC) : with prednisone in metastatic CRPC	approved	Nov 22, 2022	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	Nov 22, 2022	openfda
Docetaxel	US FDA	Malignant Breast Neoplasm	Breast Cancer (BC) : single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC	approved	Nov 22, 2022	openfda
Docetaxel	US FDA	Gastric Adenocarcinoma	Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction	approved	Nov 22, 2022	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	Nov 22, 2022	openfda
Docetaxel	US FDA	Malignant Breast Neoplasm	Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC	approved	Apr 12, 2013	openfda
Docetaxel	US FDA	Gastric Adenocarcinoma	Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction	approved	Apr 12, 2013	openfda
Docetaxel	US FDA	Castration-Resistant Prostate Carcinoma	Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer	approved	Apr 12, 2013	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	Apr 12, 2013	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	Apr 12, 2013	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	Jun 29, 2011	openfda
Docetaxel	US FDA	Castration-Resistant Prostate Carcinoma	Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer	approved	Jun 29, 2011	openfda
Docetaxel	US FDA	Gastric Adenocarcinoma	Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction	approved	Jun 29, 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	Jun 29, 2011	openfda
Docetaxel	US FDA	Malignant Breast Neoplasm	Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC	approved	Jun 29, 2011	openfda
Docetaxel	US FDA	Castration-Resistant Prostate Carcinoma	Castration-Resistant Prostate Cancer (CRPC) : with prednisone in metastatic castration-resistant prostate cancer	approved	Jun 8, 2011	openfda
Docetaxel	US FDA	Malignant Breast Neoplasm	Breast Cancer (BC) : single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC	approved	Jun 8, 2011	openfda
Docetaxel	US FDA	Gastric Adenocarcinoma	Gastric Adenocarcinoma (GC) : with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction	approved	Jun 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	Jun 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	Jun 8, 2011	openfda
Docetaxel	US FDA	Malignant Breast Neoplasm	Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC	approved	May 3, 2011	openfda
Docetaxel	US FDA	Castration-Resistant Prostate Carcinoma	Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer	approved	May 3, 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	May 3, 2011	openfda
Docetaxel	US FDA	Gastric Adenocarcinoma	Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction	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	May 3, 2011	openfda

Drug

Jurisdiction · authority

Cancer

Indication

Status

Approval date

Source

Datopotamab Deruxtecan

US FDA

Triple-Negative Breast Carcinoma

This indication is approved under accelerated approval based on objective 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 the confirmatory trial. adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy [see Clinical Studies (14.2) ] .accelerated

approved

Jan 17, 2025

Therapy	Evidence items (count)	Sensitivity / response	Resistance
Cetuximab	394	85	308
Dasatinib	287	165	122
Erlotinib	247	156	91
Imatinib	234	129	105
Crizotinib	230	130	100
Gefitinib	173	134	39
Sunitinib	155	86	68
Vemurafenib	129	86	42
Panitumumab	126	33	93
Trastuzumab	119	83	36
Afatinib	114	106	8
Trametinib	110	89	21
Olaparib	100

Approvals by jurisdiction

Therapies appearing in curated evidence