EU regulator backs AstraZeneca breast cancer pill amid US divide

EMA committee recommends camizestrant approval, breaking with FDA advisory panel's skepticism over trial design

Europe's medicines regulator has recommended approval of AstraZeneca's (AZN) experimental breast cancer treatment camizestrant, putting it at odds with an American advisory panel that raised concerns about the drug last month.

The Committee for Medicinal Products for Human Use, the European Medicines Agency's scientific body, issued its positive opinion on Friday, clearing the way for a formal decision by the European Commission to authorize the drug's use in combination with a class of therapies known as CDK4/6 inhibitors.

The recommendation follows a setback for the Anglo-Swedish pharmaceutical group earlier this month, when a panel of outside advisers to the US Food and Drug Administration voted against the treatment. The American experts directed their criticism not at the drug's safety or clinical effectiveness, but at the design of the pivotal late-stage trial on which the application rested.

The EMA's assessment was grounded in findings from that same study, which showed that camizestrant, used alongside other cancer medicines, reduced the risk of disease progression or death by 56 per cent. Patients receiving the combination therapy had their disease held in check for approximately 16 months on average, against just over nine months for those on standard treatment.

Susan Galbraith, who oversees oncology research at AstraZeneca, described Friday's recommendation as "an important first step" and said the company would engage with individual countries on market access once formal approval was granted. She added that discussions with US regulators were continuing, and that additional trial data would be presented at a medical conference later this month.

"We're really pleased to see that the CHMP has recognized the value of this monitoring approach," Galbraith said, referring to the committee by its initials.

Camizestrant occupies a central place in AstraZeneca's commercial ambitions. The company has identified it as one of 20 new medicines it expects to launch by 2030 in pursuit of an $80bn revenue target, and projects the drug could generate more than $5bn in peak annual sales.

The FDA is not bound by the recommendations of its advisory committees and may yet diverge from their opinion. AstraZeneca will be hoping the additional data it plans to disclose at the forthcoming conference is sufficient to address the trial design concerns that gave American regulators pause.