MinhTri Nguyen, Medical Oncologist and Hematologist, shared a post on LinkedIn:
“From SERENA-6 ODAC meeting: 6-3 against is a meaningful negative signal.
Bear in mind: An ODAC meeting does not automatically mean approval or rejection. It means the FDA sees an issue important enough to ask an external advisory committee to discuss and often vote on.
Thoughts:
- Trial design insufficient to answer the clinical question (Not that Cami isn’t effective (PFS hazard ratio of 0.44 is real) just that it doesn’t answer the question: whether ctDNA-guided early switching is better than switching at radiographic progression.
- The 21.0 vs 6.4 month time-to-deterioration delta is genuinely impressive and may have influenced some of the yes votes.
awaiting the PDUFA date and FDA final say.”
AstraZeneca’s Camizestrant Faces FDA ODAC Review In ESR1-Mutated HR+/HER2− Breast Cancer
