The FDA's Approval Paradox: Breakthroughs Patients Can't Reach and Trials That Collapse

The FDA has just approved AstraZeneca's breast cancer pill camizestrant (Etcamah), granting accelerated approval for hormone receptor-positive/HER2-negative breast cancer despite its own advisory committee voting against it earlier this year. The decision marks a first-in-oncology milestone: treatment is now being switched based on circulating tumor DNA (ctDNA) detection of ESR1 resistance mutations—not waiting for the cancer to visibly progress. In the SERENA-6 trial, the...