| Crizotinib | US FDA | Anaplastic Large Cell Lymphoma | o Limitations of Use: The safety and efficacy of XALKORI have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL. • adult and pediatric patients 1 year of age and older with unresectable, recurrent, or refractory inflammatory myofibroblastic tumor (IMT) that is ALK-positive. | approved | Sep 7, 2023 | openfda |
| Crizotinib | US FDA | Anaplastic Large Cell Lymphoma | pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive. | approved | Sep 7, 2023 | openfda |
| Crizotinib | US FDA | Anaplastic Large Cell Lymphoma | pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive. | approved | Aug 26, 2011 | openfda |
| Crizotinib | US FDA | Anaplastic Large Cell Lymphoma | o Limitations of Use: The safety and efficacy of XALKORI have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL. • adult and pediatric patients 1 year of age and older with unresectable, recurrent, or refractory inflammatory myofibroblastic tumor (IMT) that is ALK-positive. | approved | Aug 26, 2011 | openfda |
| Cyclophosphamide | US FDA | Retinoblastoma | retinoblastoma | approved | Sep 12, 2023 | openfda |
| Cyclophosphamide | US FDA | Ovarian Adenocarcinoma | adenocarcinoma of the ovary | approved | Sep 12, 2023 | openfda |
| Cyclophosphamide | US FDA | Multiple Myeloma | multiple myeloma | approved | Sep 12, 2023 | openfda |
| Cyclophosphamide | US FDA | Mycosis Fungoides | mycosis fungoides (advanced disease) | approved | Sep 12, 2023 | 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 | Mar 16, 2023 | 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 | Mar 16, 2023 | openfda |
| Dabrafenib | US FDA | Melanoma | TAFINLAR is indicated, in combination with trametinib , for: the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test. | approved | Mar 16, 2023 | openfda |
| Dabrafenib | US FDA | Melanoma | TAFINLAR is a kinase inhibitor indicated as a single agent for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test. | approved | Mar 16, 2023 | openfda |
| Dabrafenib | US FDA | Melanoma | the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection. | approved | Mar 16, 2023 | openfda |
| 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 | Mar 16, 2023 | openfda |
| Dabrafenib | US FDA | Melanoma | the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection. | approved | May 29, 2013 | openfda |
| 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 | 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 |
| 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 | Melanoma | TAFINLAR is indicated, in combination with trametinib , for: the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test. | approved | May 29, 2013 | openfda |
| Dabrafenib | US FDA | Melanoma | TAFINLAR is a kinase inhibitor indicated as a single agent for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test. | 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 | 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 | 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 |
| 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 |
| 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 |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 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 | 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 |