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.