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Endpoints·Sep 7·1 min read
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FDA grants accelerated approval to AstraZeneca's oral SERD for breast cancer despite advisory panel opposition

Sep 7, 2026·read at Endpoints ↗ApprovalPositive

FDA granted accelerated approval to AstraZeneca's oral selective estrogen receptor degrader, Camizestrant, for a specific group of breast cancer patients.

The approval was issued on Friday even though the FDA's advisory committee voted against it in April, citing concerns about the supporting data.

Regulators determined that the drug meets the criteria for accelerated approval, allowing it to be marketed while additional confirmatory trials are completed.

source

This writeup was produced by pharmadog from original reporting by Endpoints.

Original headline: “FDA approves AstraZeneca’s oral SERD for breast cancer despite negative adcomm vote”

read at Endpoints ↗
80 words · retrieved Sep 7
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companies & drugs in this story

companies
ASTRAZENECA3
drugs
camizestrant2
topics
Small Molecule5Approval4AdCom3Breast Cancer3Oncology3

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