FDA Advisory Committee to Review AstraZeneca's Cancer Drug Applications Amid Concerns
The FDA is set to hold its first drug-related advisory committee meeting in nine months to evaluate AstraZeneca's applications for two cancer drugs. The meeting will focus on the oral SERD drug camizestrant for HR-positive, HER2-negative breast cancer and the AKT inhibitor Truqap for metastatic hormone-sensitive prostate cancer. The FDA has raised questions about the clinical benefits and trial designs of these drugs, particularly regarding the validity of results and the timing of treatment interventions. The advisory panel will assess whether AstraZeneca has provided sufficient evidence to support the clinical benefits of these drugs.