The U.S. Food and Drug Administration (FDA) has announced it will convene a meeting of its Oncologic Drugs Advisory Committee (ODAC) on April 30, 2026. The committee will review two marketing applications submitted by AstraZeneca PLC (AZN.US). The first application is for the oral SERD drug Camizestrant, used in combination with a CDK4/6 inhibitor, for the first-line treatment of locally advanced or metastatic HR+/HER2- breast cancer with ESR1 mutations. The second application is for the AKT inhibitor Capivasertib, used in combination with abiraterone, for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) with PTEN deficiencies.
Camizestrant is a next-generation oral selective estrogen receptor degrader (SERD) developed by AstraZeneca. The drug has already been submitted for marketing approval in the United States, Europe, and Japan. Capivasertib is a highly selective inhibitor of AKT1/2/3, also developed by AstraZeneca. Activation of the AKT signaling pathway, which can involve alterations in genes such as PIK3CA, AKT1, and PTEN, is observed in many patients with advanced HR+/HER2- breast cancer. It can also occur in patients without these specific genetic changes. The AKT pathway is associated with the development of resistance to endocrine therapy.
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