FDA has accepted the supplemental New Drug Application for Augtyro (repotrectinib) for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, and are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity.
FDA accepted the supplemental Biologics Application for neoadjuvant Opdivo (nivolumab) with chemotherapy followed by surgery and adjuvant Opdivo for the perioperative treatment of resectable stage 2A to 3B non-small cell lung cancer. FDA assigned a Prescription Drug User Fee Act goal date of Oct. 8.
FDA has directed the sponsors of CAR T-cell therapies to place boxed warnings on their products to indicate that the agents may cause secondary T-cell malignancies.
The story of Janet Woodcock’s illustrious career is not just one of professional achievements; it’s a tale of enduring partnerships, empathetic leadership, and unwavering commitment to science and patient care that will continue as she leaves public service this year.
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.
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).
