For the second time in less than a month, a drug maker has pulled an indication for a medicine after a follow-up clinical trial failed to meet its primary goal. And the moves come as part of a U.S. regulatory review of so-called accelerated approvals, a controversial strategy that has been used to hasten availability of treatments for serious conditions.
The latest reversal concerns Tecentriq, a Roche (RHHBY) drug that was granted accelerated approval in 2016 to treat bladder cancer, but a trial to confirm the benefits subsequently showed it failed to improve overall survival. Last month, AstraZeneca (AZN) withdrew a bladder cancer indication for Imfinzi after a follow-up trial also showed the drug failed to improve overall survival.
Unlock this article by subscribing to STAT+ and enjoy your first 30 days free!
GET STARTEDWhat is it?
STAT+ is STAT's premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond.
What's included?
- Daily reporting and analysis
- The most comprehensive industry coverage from a powerhouse team of reporters
- Subscriber-only newsletters
- Daily newsletters to brief you on the most important industry news of the day
- STAT+ Conversations
- Weekly opportunities to engage with our reporters and leading industry experts in live video conversations
- Exclusive industry events
- Premium access to subscriber-only networking events around the country
- The best reporters in the industry
- The most trusted and well-connected newsroom in the health care industry
- And much more
- Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr.
About the Author Reprints
