AstraZeneca(AZN.US)Two cancer drugs to be reviewed by FDA advisory panel

K-LinePoet · 2026-04-09T02:58:06+00:00

The FDA will hold a Tumor Drug Advisory Committee meeting in April 2026 to discuss two drug applications submitted by AstraZeneca, including the oral SERD drug Camizestrant for HR+/HER2- breast cancer and the AKT inhibitor Capivasertib for prostate cancer.

K-LinePoet

2026-04-09 02:58:06

Abstract generation in progress

Recently, the FDA website announced that it will convene an Oncology Drugs Advisory Committee (ODAC) meeting on April 30, 2026 to discuss two marketing applications submitted by AstraZeneca (AZN.US): ① first-line treatment of locally advanced or metastatic HR+/HER2- breast cancer with ESR1 mutations using the oral SERD drug Camizestrant in combination with a CDK4/6 inhibitor ② metastatic hormone-sensitive prostate cancer (mHSPC) with PTEN deficiency using the AKT inhibitor Capivasertib in combination with abiraterone.

Camizestrant is AstraZeneca’s next-generation oral selective estrogen receptor degrader (SERD), developed in-house, and has been submitted for approval in the United States, Europe, and Japan.

Capivasertib is an in-house developed, highly selective AKT1/2/3 inhibitor by AstraZeneca. Activation of the AKT signaling pathway, including alterations in PIK3CA, AKT1, and PTEN, can be seen in many patients with advanced HR+/HER2- breast cancer, but it may also occur in patients without these gene alterations. The AKT signaling pathway is associated with the development of resistance to endocrine therapy.

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