| 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 | 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 | 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 | 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 | 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 |
| 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 |
| 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 | 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 |
| 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 | 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 | 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 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 | 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 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
| 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 |