FDA Advisory Committee Faces Challenges in Evaluating AstraZeneca's Cancer Drug
The FDA's Oncologic Drugs Advisory Committee (ODAC) recently convened to discuss AstraZeneca's cancer drug camizestrant, marking the first drug-related advisory meeting in nine months. This session was notable for being the first without the presence of Richard Pazdur, a key figure in oncology at the FDA. The committee focused on the Phase 3 SERENA-6 trial, which evaluated camizestrant in combination with a CDK4/6 inhibitor for HER2-negative advanced breast cancer. The trial did not demonstrate a statistically significant overall survival benefit, leading to a 6-3 vote against the drug's approval for this patient population. Despite this, the FDA and AstraZeneca clarified that the trial was not designed to detect overall survival benefits. The meeting highlighted ongoing debates about trial designs and the clinical significance of progression-free survival. 
