Enfortumab Progresses As US Accelerated Approval Eyed In Urothelial Cancer
Astellas and Seattle Genetics now expect key top-line data on their antibody-drug conjugate in urothelial cancer in the first half of next year, as pivotal trials in support of a planned US accelerated approval progress.
You may also be interested in...
The combination of Adcetris with chemotherapy improved progression-free and overall survival in peripheral T-cell lymphoma. Filing is expected soon, and approval will help the product reach blockbuster status.
FDA’s most recent accelerated approvals for Merck’s Keytruda call for confirmatory trials in a broader patient population than the approved indications, in the latest example of FDA’s growing comfort with multi-purpose confirmatory trials in the PD-1/PD-L1 inhibitor space.
US FDA's latest BTD awards go to Seattle Genetics and Astellas' antibody-drug conjugate for immunotherapy-experienced urothelial cancer, Fennec's supportive care product to reduce cisplatin ototoxicity in pediatric cancer patients, and Bristol's double immunotherapy combo in MSI-H colorectal cancer.