The Food and Drug Administration has postponed its approval decision for AstraZeneca’s investigational breast cancer medication camizestrant while officials examine additional information, the pharmaceutical company announced Wednesday.
The postponement follows an April meeting where most members of an FDA advisory committee recommended against approving the medication when used alongside CDK4/6 inhibitor therapy. The panel’s concerns centered on how a crucial late-stage clinical study was structured, rather than questions about the drug’s safety or effectiveness.
The Anglo-Swedish pharmaceutical company reported it has provided extra analysis that FDA officials requested to support the medication’s approval application. This includes information about long-term effectiveness results that will be shared at a conference scheduled for June 2.
“We look forward to continuing the dialogue with the FDA in order to bring the benefits of camizestrant with this innovative treatment strategy to eligible patients in the US as quickly as possible,” said Susan Galbraith, a senior executive at AstraZeneca, in a statement.
The camizestrant medication targets patients diagnosed with a particular form of breast cancer where tumors contain a specific genetic mutation.
European regulators took a different approach last week, with the European Medicines Agency’s Committee for Medicinal Products for Human Use endorsing the drug’s approval.
