AstraZeneca Says Breast Cancer Treatment Granted US FDA Priority Review

MT Newswires Live
02/03

AstraZeneca (AZN) said Tuesday the US Food and Drug Administration granted priority review for its and Daiichi Sankyo's supplemental biologics license application for Datroway to treat a specific form of metastatic breast cancer.

The review period covers adult patients with triple-negative breast cancer who are ineligible for immunotherapy treatments, the company said.

Study results showed the medication had a 5-month improvement in median overall survival and showed a "robust and durable" response compared with traditional chemotherapy, AstraZeneca said.

The regulatory agency expects to issue a decision on the application during Q2, the company said.

Datroway is also being evaluated by international health authorities through a concurrent submission framework called Project Orbis, designed to accelerate oncology reviews, it said.

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