Photo from Harpreet Singh/LinkedIn
Aug 3, 2024, 10:13
Harpreet Singh: ODAC vote marks a pivotal moment in oncology drug development
Harpreet Singh,
“The recent FDA Oncologic Drugs Advisory Committee (ODAC) vote marks a pivotal moment in oncology drug development, particularly for perioperative regimens.
In my latest video, I break down:
- The unanimous ODAC vote on future perioperative trial designs
- FDA’s concerns about potential overtreatment in resectable lung cancer
- Implications for drug developers across multiple cancer types
Key insights:
- The need for higher standards in approving long-term post-surgery treatments
- How this vote could influence trial designs beyond lung cancer
- Potential requirement for additional trial arms to justify treatment phases
This decision raises important questions about balancing innovation with patient safety. The FDA is signaling a need for more robust evidence to justify perioperative immunotherapy regimens, particularly in cancers where surgery alone might be curative.
What challenges do you foresee in implementing these new trial design requirements? How might this impact the timeline for bringing new treatments to patients?”
Link to video.
Source: Harpreet Singh/LinkedIn
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