FDA grants accelerated approval to AstraZeneca's oral SERD for breast cancer despite advisory panel opposition
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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