FDA Oncologic Drugs Advisory Committee Reviews Camizestrant for ESR1-Mutant Breast Cancer

The FDA's Oncologic Drugs Advisory Committee convened on April 30, 2026 to review AstraZeneca's camizestrant tablets — an oral, non-steroidal selective estrogen receptor degrader (SERD) — in combination with a CDK4/6 inhibitor for HR+/HER2-negative locally advanced or metastatic breast cancer in patients with ESR1 mutations emerging during first-line endocrine therapy. ESR1 mutations are a key acquired resistance mechanism in metastatic hormone receptor-positive breast cancer and occur in roughly 30-40% of patients after aromatase inhibitor treatment. The AdCom also reviewed Truqap (capivasertib) plus abiraterone acetate for PTEN-deficient metastatic hormone-sensitive prostate cancer. Advisory committee panel votes inform but do not bind FDA final approval decisions. Camizestrant represents the next generation of oral SERDs designed to overcome acquired endocrine resistance and could become a preferred option in ESR1-mutated metastatic breast cancer after fulvestrant.