A5025880825- Cancer Immunotherapy and Biomarkers
- Bladder and Urothelial Cancer Treatments
- Urinary and Genital Oncology Studies
- Prostate Cancer Treatment and Research
- Renal cell carcinoma treatment
- Biomedical Ethics and Regulation
- Cancer, Lipids, and Metabolism
- Multiple and Secondary Primary Cancers
- Economic and Financial Impacts of Cancer
- Cancer Genomics and Diagnostics
- PARP inhibition in cancer therapy
- Health Systems, Economic Evaluations, Quality of Life
- Ethics in Clinical Research
- Radiopharmaceutical Chemistry and Applications
- Chronic Lymphocytic Leukemia Research
- DNA Repair Mechanisms
- Cancer Diagnosis and Treatment
- Chronic Myeloid Leukemia Treatments
- Inflammatory Biomarkers in Disease Prognosis
- Aortic aneurysm repair treatments
- Pharmaceutical industry and healthcare
- Cancer, Hypoxia, and Metabolism
- Cancer therapeutics and mechanisms
- Ovarian cancer diagnosis and treatment
- Hematopoietic Stem Cell Transplantation
Center for Drug Evaluation and Research
2006-2024
United States Food and Drug Administration
2006-2024
To assess the relationship among tumor response rate, overall survival, and development of related adverse events special interest (AESIs) or immune-mediated (imAEs) in patients with urothelial cancer treated anti-programmed death protein 1 ligand (anti-PD-1/L1) antibodies.We examined seven trials 1,747 metastatic locally advanced that led to approval an anti-PD-1/L1 antibody. Five enrolled who had received prior platinum-based therapy, two were cisplatin ineligible. The data sets searched...
On August 13, 2021, the FDA approved belzutifan (WELIREG, Merck), a first-in-class hypoxia-inducible factor (HIF) inhibitor for adult patients with von Hippel-Lindau (VHL) disease who require therapy associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery. The granted approval based on clinically meaningful effects overall response rate (ORR) observed in enrolled Study MK-6482-004. All...
On June 28, 2006, the U.S. Food and Drug Administration approved dasatinib (Sprycel; Bristol-Myers Squibb), a new small-molecule inhibitor of multiple tyrosine kinases, for treatment adults with chronic phase, accelerated or myeloid lymphoid blast phase leukemia (CML) Philadelphia chromosome-positive acute lymphoblastic (Ph(+) ALL) resistance intolerance to prior therapy including imatinib. This summary reviews database supporting this approval.Four single-arm multicenter studies supported...
The US Food and Drug Administration (FDA) approved talazoparib with enzalutamide for first-line treatment of patients homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC).
<i>Purpose:</i> On December 15, 2008, the US Food and Drug Administration approved plerixafor (Mozobil®; Genzyme Corp.), a new small-molecule inhibitor of CXCR4 chemokine receptor, for use in combination with granulocyte colony-stimulating factor (G-CSF) to mobilize hematopoietic stem cells (HSC) peripheral blood collection subsequent autologous transplantation patients non-Hodgkin’s lymphoma (NHL) multiple myeloma (MM). This summary reviews database supporting this approval....
This article summarizes the US Food and Drug Administration (FDA) review of data leading to approval olaparib plus abiraterone for treatment patients with deleterious or suspected
On April 25, 2016, the FDA approved cabozantinib (Cabometyx; Exelixis, Inc.) for treatment of advanced renal cell carcinoma (RCC) in patients who have received prior antiangiogenic therapy. The approval was based on data from one randomized, open-label, multicenter study which with RCC had therapy were treated either 60 mg orally once daily (n = 330) or everolimus 10 328). major efficacy outcome measure progression-free survival (PFS) as assessed by a blinded independent radiology review...
Abstract The U.S. Food and Drug Administration approved enzalutamide for the treatment of patients with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC). At prespecified interim analysis, a statistically significant improvement in overall survival was demonstrated arm compared placebo arm. benefit-risk profile supports expanded indication enzalutamide. On September 10, 2014, Enzalutamide initially 2012 use mCRPC who had previously received docetaxel. current...
Abstract On December 15, 2023, the FDA granted traditional approval to enfortumab vedotin-ejfv plus pembrolizumab (EV + Pembro) for patients with locally advanced or metastatic urothelial carcinoma (la/mUC). Substantial evidence of effectiveness was obtained from EV-302/KEYNOTE-A39 (NCT04223856), an open-label, randomized trial evaluating EV Pembro versus cisplatin carboplatin gemcitabine (Plat Gem) in previously untreated la/mUC. A total 886 were (1:1) receive 1.25 mg/kg intravenously on...
4559 Background: The International Metastatic RCC Database Consortium (IMDC) risk model was developed for prognosis of patients with mRCC treated vascular endothelial growth factor (VEGF)-targeted monotherapy in the first-line setting. Efficacy trials anti-VEGF therapy has been generally consistent across groups, including overall survival (OS). For immunotherapy combinations, small numbers OS events favorable group each trial limited reliable conclusions; however, there a suggestion...
4557 Background: Previous data has suggested that patients treated with anti-PD-1/L1 antibodies who receive antibiotics during their therapy might have dramatically decreased progression-free and overall survival 1,2 . This clinical implications for management of suspected bacterial infection while on treatment these agents. We assessed the relationship between antibiotic use tumor response rate, survival, in a large dataset urothelial cancer antibodies. Methods: examined seven trials led to...
<p>Kaplan-Meier curves of overall survival in EV-302</p>
<div>Abstract<p>On December 15, 2023, the FDA granted traditional approval to enfortumab vedotin-ejfv plus pembrolizumab (EV + Pembro) for patients with locally advanced or metastatic urothelial carcinoma (la/mUC). Substantial evidence of effectiveness was obtained from EV-302/KEYNOTE-A39 (NCT04223856), an open-label, randomized trial evaluating EV Pembro versus cisplatin carboplatin gemcitabine (Plat Gem) in previously untreated la/mUC. A total 886 were (1:1) receive 1.25 mg/kg...
<p>Kaplan-Meier curves of BICR-assessed progression-free survival in EV-302</p>