Source: Sharecast
The FDA's Oncologic Drugs Advisory Committee (ODAC) voted three to six against recommending 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.
The company is looking for FDA approval to use the drug as a first-line treatment for patients with hormone receptor-positive, HER2-negative advanced breast cancer whose tumours have an emergent ESR1 mutation.
"The FDA is not bound by the committee's guidance but takes its advice into consideration. AstraZeneca will continue to work with the FDA as it completes its review of the application," the company said in a statement on Friday. Shares in the company were down 1.8% in London trade.
In a separate decision the ODAC voted seven-to-one in favour of the company’s prostate cancer drug Truqap, or capivasertib, combined with abiraterone and androgen deprivation therapy.
Reporting by Frank Prenesti for Sharecast.com
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