AstraZeneca has suffered a setback after a US FDA advisory committee stopped short of endorsing its experimental breast cancer treatment, voting against its benefit–risk profile in a closely split decision.

 

The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 3 to 6 against recommending camizestrant in combination with a CDK4/6 inhibitor—palbociclib, ribociclib or abemaciclib—for first-line treatment of patients with hormone receptor (HR)-positive, HER2-negative advanced breast cancer whose tumours develop emergent ESR1 mutations.

 

The decision was based on results from the Phase III SERENA-6 trial.

 

The outcome marks a notable hurdle for AstraZeneca, even as the company continues to press its case during the FDA’s ongoing review. While the agency is not bound by ODAC’s recommendation, it typically weighs the committee’s views heavily in final decisions.

 

Despite the setback, investigators and the company defended the therapy’s clinical profile.

 

Kevin Kalinsky, Division Director of Medical Oncology at Winship Cancer Institute of Emory University and a trial investigator, said: “Patients with this specific form of breast cancer are in urgent need of new treatments that delay disease progression. 

 

"Today’s recommendation by the ODAC is disappointing, as new options and innovative treatment strategies which address emerging resistance ahead of disease progression and deterioration in quality of life are needed in the 1st-line setting.”

 

AstraZeneca also pushed back on the committee’s decision.

 

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: “New innovations and novel treatment strategies that provide benefit to patients are required to drive advances in this 1st-line setting, and so we are disappointed with the mixed outcome of today’s ODAC meeting. 

 

"We strongly believe in the results of the SERENA-6 trial, and are encouraged that the Committee saw camizestrant as a safe and effective potential new medicine. We remain confident in the clinical benefit the combination can bring to patients by changing therapeutic strategy at the earliest opportunity, and are committed to challenging the status quo in the pursuit of innovation that optimises outcomes for patients.”

 

The SERENA-6 trial had previously shown striking efficacy signals.