AstraZeneca's Breast-Cancer Candidate Drug Loses FDA Panel Vote — Update

By Ian Walker and Joshua Kirby

British pharmaceutical group AstraZeneca said it would continue to work with U.S. regulators on a review of its breast-cancer candidate after the drug failed to get backing at a key advisory committee vote.

The Food and Drug Administration's oncologic drugs advisory committee voted six to three against the benefit-risk profile of camizestrant, a candidate drug for the treatment of breast cancer, the FTSE 100-listed drugmaker said late Thursday.

"AstraZeneca will continue to work with the FDA as it completes its review of the application," it said. The regulator isn't bound by the committee's guidance, but takes its advice into consideration.

"We strongly believe in the results of the Serena-6 trial [testing camizestrant], and are encouraged that the committee saw camizestrant as a safe and effective potential new medicine," Astra's Susan Galbraith said.

There were some positive signs for the drug's future from the committee meeting, Citi analysts wrote.

"Importantly for the ongoing trials larger settings, [those who voted against the profile] didn't seem to harbor significant concerns over toxicity," Citi said.

The drugmaker earlier this week said cancer drugs were core to revenue growth over the year's first quarter, with oncology posting double-digit growth from a year prior. AstraZeneca has in recent years bet on its oncology business to spur growth, bringing new drugs to market and working to expand the labels of existing medicines. Oncology now accounts for close to half of group revenue.

The knockback for camizestrant isn't a serious issue for the stock, analysts at Jefferies said.

"Outside of a potential sentiment hit, this should not be a major issue, and any weakness presents a buying opportunity," the bank told investors in a note. Shares in AstraZeneca lost around 1.8% in Friday's opening trading.

Write to Ian Walker at ian.walker@wsj.com and to Joshua Kirby at joshua.kirby@wsj.com; @joshualeokirby

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May 01, 2026 04:01 ET (08:01 GMT)