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FDA Grants Priority Review to Pembrolizumab/Chemoradiotherapy in Cervical Cancer
September 20th 2023A supplemental biologics license application seeking the approval of pembrolizumab, external beam radiotherapy, and concurrent chemotherapy, followed by brachytherapy has been accepted for priority review by the FDA for advanced cervical cancer.
Nivolumab/Ipilimumab Continues to Show OS Benefit in NSCLC at 6 Years
September 18th 2023With a minimum of 73.5 months of follow-up, nivolumab plus ipilimumab showed a benefit in overall survival in patients with treatment-naive stage IV or recurrent non–small cell lung cancer with no known EGFR/ALK alterations.
FDA Receives Rolling NDA of Tovorafenib for Pediatric Low-Grade Glioma
September 14th 2023Data from the phase 2 FIREFLY-1 trial support the new drug application for tovorafenib in relapsed or progressive pediatric low-grade glioma. The regulatory agency anticipates filing the application by mid-November 2023
Ivaltinostat Combinations Show Promise for Pancreatic Adenocarcinoma
September 13th 2023In an interview, Mohamad Adham Salkeni, MD, FRCPC, discussed the ongoing study of maintenance ivaltinostat plus capecitabine or capecitabine monotherapy in patients with metastatic pancreatic adenocarcinoma whose disease has not progressed on first-line FOLFIRINOX.