AstraZeneca Says Breast Cancer Treatment Granted US FDA Priority Review

MT Newswires Live
Feb 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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