Based on promising response data from the Phase I/II TRIDENT-1 study, the FDA on Thursday granted Bristol Myers Squibb’s Augtyro accelerated approval for NTRK-positive locally advanced or metastatic solid tumors.
Tag Archive for: FDA accelerated approval
Accelerated approval allows the FDA to rely on surrogate or intermediate clinical endpoints to approve therapies in a shorter time frame than would be possible with traditional endpoints, but it has come under scrutiny by some policymakers and researchers in recent years.
Recent U.S. policy changes and the introduction of the Inflation Reduction Act (IRA) have injected a sense of urgency within pharma companies for greater cross functional cooperation. The traditional route that drugs take through the development process from bench to patient needs a radical rethink. Any pressure on how drugs are assessed through the AA route will further ramp up the urgency within pharma to align internally.