Bristol Myers’ KRAS Confirmatory Data Avoid Amgen’s Flaws but Leave FDA Prospect Unclear

1. Bristol Myers' KRAS Data: Bristol Myers Squibb has provided details of its KRAS confirmatory data, which avoid the flaws seen in Amgen's rejected trial results.
2. Amgen's Rejected Trial: The FDA rejected Amgen's KRAS confirmatory trial results as uninterpretable.
3. Accelerated Approval Pathway: The FDA's accelerated approval pathway, used for oncology therapies, requires confirmatory trials to prove benefits. However, many approved drugs have failed to demonstrate survival benefits in these trials.
4. Study on Accelerated Approvals: A recent study found that among 129 accelerated approvals, 63% were converted to traditional approvals, but less than half (43%) proved clinically beneficial in confirmatory trials.
5. Industry Defense: The Pharmaceutical Research and Manufacturers of America (PhRMA) defends the accelerated approval program, citing its success in providing timely access to treatments.
6. FDA Concerns: The FDA has expressed concerns over extended timelines for confirmatory studies and has urged companies to reduce the time to prove clinical benefits.
7. Regeneron's Rejected Applications: The FDA recently rejected two of Regeneron's applications due to a lack of progress on confirmatory trials.