AstraZeneca reported that the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted that camizestrant in combination with a CDK4/6 inhibitor has not demonstrated a clinically meaningful benefit for the proposed indication in hormone receptor (HR)-positive, HER2‑negative locally advanced or metastatic breast cancer with an ESR1 mutation. The proposed use was in adult patients whose tumors develop an ESR1 mutation during first-line endocrine-based therapy, prior to radiographic disease progression.
The ODAC decision was based on data from the Phase III SERENA‑6 trial, which evaluated switching from an aromatase inhibitor to camizestrant while continuing CDK4/6 inhibitor treatment at the time an ESR1 mutation was detected. In the committee’s vote, members concluded that the trial results did not establish that camizestrant provided a clinically meaningful benefit in this setting. The ODAC’s vote is advisory, and the FDA will consider the committee’s recommendation in its ongoing review of the new drug application for camizestrant.
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