A Cancer Innovation Crisis? Misplaced Incentives Promote Marginal Benefits, JAMA Study Says
A study of oncology approvals since 2002 concludes that only 42% represented a “clinically meaningful improvement” in therapy. High prices encourage a “me-too” mentality that directs R&D investment to marginal indications, the authors assert.
You may also be interested in...
American Society of Clinical Oncology draft recommendations provide benchmarks for Phase III oncology drug trials, including a minimum 20% improvement in overall survival, with a higher bar for certain diseases.
Most requests for the FDA’s less-heralded expedited review designation are based on Phase II or earlier data, and have a greater chance of success than requests for breakthrough designation.
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.