AstraZeneca Says FDA Extends Regulatory Review of New Drug Application of its Combination Breast Cancer Treatment

[출처/시간] MT Newswires - 3:40 AM ET, 05/27/2026

03:40 AM EDT, 05/27/2026 (MT Newswires) -- AstraZeneca (AZN) said Wednesday the US Food and Drug Administration delayed the decision deadline for its new drug application regarding a combination breast cancer treatment to evaluate additional information.

The regulator requested further details regarding the proposed use of camizestrant alongside a cyclin-dependent kinase inhibitor for treating specific advanced breast tumors, the company said.

The drugmaker submitted an extra effectiveness analysis to the authorities to support the approval request after a government advisory committee previously failed to reach a consensus regarding the clinical benefits of the therapy during an April meeting, AstraZeneca said.

The company also said a European regulatory panel recently recommended the drug combination for approval, while health officials in Japan continue to review the medication.