April 30 (Reuters) – A panel of outside experts to the U.S. Food and Drug Administration voted against backing the risk-benefit profile of AstraZeneca’s breast cancer drug, the company said on Thursday.
The FDA’s Oncologic Drugs Advisory Committee voted 3 to 6 against AstraZeneca’s experimental oral drug camizestrant, which is being developed as a first-line treatment for a type of breast cancer whose tumors have a specific mutation.
Here are some more details:
• Six members voted against it because they disagreed with the trial design.
• AstraZeneca said it was “disappointed” by the outcome but remains confident in the drug’s benefit, citing a favorable safety profile.
• In a late-stage trial, the drug in combination with other cancer medicines reduced the risk of cancer progression or death by 56%, keeping the disease under control for about 16 months on average, compared with just over nine months with standard treatment.
• The advisory panel expressed some concerns with the treatment and trial design, including whether there was a long-term benefit for patients.
• The FDA typically follows the advice of its experts but is not bound to do so.
• Given the FDA’s apparent opposition to approval in the briefing documents and the negative vote, J.P. Morgan analyst Richard Vosser said it is unlikely that camizestrant will be approved based on the study results.
(Reporting by Sri Hari N S, Rishab Shaju and Sriparna Roy in Bengaluru; Editing by Tasim Zahid)
