FDA Grants Breakthrough Therapy Designation for AstraZeneca's Imfinzi

The U.S. Food and Drug Administration has agreed to speed up the process required for development and regulatory review of AstraZeneca PLC's (AZN.LN) new lung cancer drug Imfinzi (durvalumab).

Pharmaceutical firm AstraZeneca and MedImmune, its global biologics research and development arm, said Monday that the FDA has granted Breakthrough Therapy Designation for Imfinzi (durvalumab) for the treatment of patients with locally-advanced, unresectable non-small cell lung cancer whose disease has not progressed following platinum-based chemoradiation therapy.

The Breakthrough Therapy Designation is designed to expedite the development and regulatory review of new medicines that are intended to treat a serious condition and that have shown encouraging early clinical results, which demonstrate substantial improvement on a clinically-significant endpoint over available medicines and when there is significant unmet medical need.

"Imfinzi is the first immuno-oncology medicine to show a clinically-significant benefit in this earlier, non-metastatic setting, so following the Breakthrough Designation we hope to bring it to patients as soon as possible," Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said.

Write to Razak Musah Baba at razak.baba@wsj.com; Twitter: @Raztweet

(END) Dow Jones Newswires

July 31, 2017 02:33 ET (06:33 GMT)