May 1 (Reuters) – AstraZeneca shares fell 1.9% on Friday after an advisory panel for the U.S. Food and Drug Administration overnight voted against recommending the drugmaker’s experimental breast cancer treatment, casting some doubts over approvals for the key drug.
The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 3 to 6 against camizestrant, which is being developed for a type of breast cancer in which tumours have a specific mutation, citing concerns about study design rather than safety or efficacy itself.
AstraZeneca expressed disappointment over the vote, but remained confident in the drug’s potential and would continue working with the FDA.
The regulator typically follows the advice of its expert advisers but is not bound by their recommendations.
Shares of the FTSE 100-listed drugmaker have gained nearly 30% over the past year, but on Friday they were underperforming the benchmark index, which was down 0.3%.
Analysts appeared largely unfazed, as the panel did not question camizestrant’s potential but rather the design of the trials. That suggests the drug could still win approval based on data from other trials, they said.
(Reporting by Raechel Thankam Job in Bengaluru; Editing by Sherry Jacob-Phillips)
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