FDA approved Balversa (erdafitinib) for adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations, as determined by an FDA-approved companion diagnostic test, whose disease has progressed on or after at least one line of prior systemic therapy.Â
Kelly J. Norsworthy was named acting associate director for research mentorship in FDA’s Oncology Center of Excellence.
FDA approved Keytruda (pembrolizumab) with chemoradiotherapy for patients with FIGO 2014 stage 3-4A cervical cancer.
Multi-cancer detection tests evoke conflicting reactions—the excitement at their promise is quickly dampened by concerns over the uncertainty of their clinical benefit, very low sensitivity for detecting stage 1 cancers, and the risks that come from subsequent workups.
FDA has approved Welireg (belzutifan) for patients with advanced renal cell carcinoma (RCC) following a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI).
FDA has approved Padcev (enfortumab vedotin-ejfv) in combination with Keytruda (pembrolizumab) for patients with locally advanced or metastatic urothelial cancer (la/mUC).Â
To improve evidence generation in studies designed to bring therapeutic agents to market, FDA is urging drug sponsors not to skip dose optimization at the outset of clinical development. The agency is also telling industry that it’s open to accepting trials that have pragmatic elements and are augmented by data generated in academia.
FDA approved Welireg (belzutifan) for patients with advanced renal cell carcinoma following a PD-1 or PD-L1 inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor.
FDA approved Iwilfin (eflornithine) to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma who have demonstrated at least a partial response to prior multiagent, multimodality therapy including anti-GD2 immunotherapy.
NIH and FDA envision transforming the way clinical trials are done across the biomedical research enterprise.Â