Underlying the committee's deliberations were Phase 3 data from SERENA-6 showing that camizestrant cut the risk of disease progression or death by 56% relative to standard treatment, according to CNBC. Median progression-free survival reached 16 months among camizestrant recipients — nearly double the 9.2 months seen in patients who remained on standard-of-care regimens, Bloomberg reported. The panel did not raise significant concerns about the drug's safety or toxicity.
The panel’s main concern was about timing: they questioned whether switching patients to camizestrant before visible signs of disease progression would lead to a lasting survival benefit. The advisers did not doubt that camizestrant could be helpful, but focused their skepticism on what the trial design actually showed.
In a statement, AstraZeneca $AZN pushed back on the vote, saying it stood behind its trial data and maintained that camizestrant offers genuine benefit to patients. "We will continue to work with the FDA as it completes its review," Executive Vice President of Oncology Haematology R&D Susan Galbraith said in a statement.
Camizestrant is an oral drug designed to treat hormone receptor-positive, HER2-negative breast cancer — the most common subtype of the disease — in patients whose tumors carry a mutation in the ESR1 gene, which can drive resistance to standard therapies, AstraZeneca said.
AstraZeneca posted stronger-than-expected first-quarter results earlier this week, with total revenue rising 13% to $15.29 billion and its oncology division leading growth. At the time, CEO Pascal Soriot said the company remained on track to meet its 2030 revenue goals, with camizestrant among the drugs it hoped to bring to market in 2026 pending U.S. regulatory clearance.
