Keeping Track: Opana ER Abuse Deterrence Claim Withdrawn; Third Neulasta Biosimilar Submitted; Keytruda Cleared In Head And Neck Cancer
The latest drug development news and highlights from our FDA Performance Tracker.
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Withdrawal of sBLA for full approval of Keytruda in second-line SCCHN makes way for Merck to file for first-line use.
Prior PD-1 failures after accelerated approval include Roche's Tecentriq in bladder cancer.
As PD-1 inhibitors march toward earlier-stage head and neck cancers, researchers consider ways to improve the precision of immunotherapy through better patient selection and combinations for this accessible tumor type.