| Dabrafenib | US FDA | Lung Non-Small Cell Carcinoma | the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test. | approved | May 29, 2013 | openfda |
| Dabrafenib | US FDA | Malignant Colorectal Neoplasm | Limitations of Use : TAFINLAR is not indicated for treatment of patients with colorectal cancer because of known intrinsic resistance to BRAF inhibition. | approved | May 29, 2013 | openfda |
| Dabrafenib | US FDA | Thyroid Gland Anaplastic Carcinoma | the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation, as detected by an FDA-approved test, and with no satisfactory locoregional treatment options. | approved | May 29, 2013 | openfda |
| Dabrafenib | US FDA | Tumor-agnostic | the treatment of adult and pediatric patients 1 year of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on overall 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(s). • the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy. • TAFINLAR is not indicated for treatment of patients with wild-type BRAF solid tumors. ( 5.2 )accelerated | approved | May 29, 2013 | openfda |
| Dacomitinib | US FDA | Lung Non-Small Cell Carcinoma | VIZIMPRO is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test [see Dosage and Administration (2.1) ] . VIZIMPRO is a kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test. ( 1 ) | approved | Sep 27, 2018 | openfda |
| Dacomitinib | US FDA | Lung Non-Small Cell Carcinoma | VIZIMPRO is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test [see Dosage and Administration (2.1) ] . VIZIMPRO is a kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test. ( 1 ) | approved | Sep 27, 2018 | openfda |
| Dactinomycin | US FDA | Ewing Sarcoma | adult and pediatric patients with Ewing sarcoma, as part of a multi-phase, combination chemotherapy regimen. | approved | Nov 9, 2017 | openfda |
| Dactinomycin | US FDA | Malignant Testicular Neoplasm | adult and pediatric patients with metastatic, nonseminomatous testicular cancer, as part of a multi-phase, combination chemotherapy regimen. | approved | Nov 9, 2017 | openfda |
| Dactinomycin | US FDA | Wilms Tumor | adult and pediatric patients with Wilms tumor, as part of a multi-phase, combination chemotherapy regimen. | approved | Nov 9, 2017 | openfda |
| Dactinomycin | US FDA | Rhabdomyosarcoma | adult and pediatric patients with rhabdomyosarcoma, as part of a multiphase, combination chemotherapy regimen. | approved | Nov 9, 2017 | openfda |
| Daratumumab | US FDA | Multiple Myeloma | DARZALEX is indicated for the treatment of adult patients with multiple myeloma: in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy. in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant. in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant. in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy. in combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy. in combination with pomalidomide and dexamethasone in patients who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. as monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent. DARZALEX is a CD38-directed cytolytic antibody indicated for the treatment of adult patients with multiple myeloma: in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy in combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy in combination with pomalidomide and dexamethasone in patients who have received at least two prior therapies including lenalidomide and a proteasome inhibitor as monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent. ( 1 ) | approved | Nov 16, 2015 | openfda |
| Darolutamide | US FDA | Nonmetastatic Castration-Resistant Prostate Carcinoma | NUBEQA is an androgen receptor inhibitor indicated for the treatment of adult patients with: non-metastatic castration-resistant prostate cancer (nmCRPC). ( 1 ) metastatic castration-sensitive prostate cancer (mCSPC). ( 1 ) metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel. ( 1 ) NUBEQA is indicated for the treatment of adult patients with: non-metastatic castration resistant prostate cancer (nmCRPC) metastatic castration-sensitive prostate cancer (mCSPC) metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel. | approved | Jul 30, 2019 | openfda |
| Datopotamab Deruxtecan | US FDA | Malignant Breast Neoplasm | adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease. | 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 |
| 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 |
| 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 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 | 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 | Jun 1, 2010 | 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 |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | Castration-Resistant Prostate Carcinoma | Castration- Resistant Prostate Cancer (CRPC) : with prednisone in metastatic CRPC | 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 | Apr 12, 2013 | 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 | 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 | 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 | 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 | 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 |