AstraZeneca's Lung-Cancer Treatment Gets Recommended for Approval in the EU

By Christian Moess Laursen

AstraZeneca said its lung-cancer drug Enhertu has been recommended for approval in the European Union following positive test results.

The Anglo-Swedish pharma giant said Friday that Enhertu showed an objective response rate of 49.0% and a median duration of response of 16.8 months. In addition, the tests showed a disease control rate of 93.1%.

The drug has been recommended for approval as a monotherapy for the treatment of adult patients with advanced non-small-cell lung cancer whose tumors have an activating HER2 mutation.

This form of lung cancer is an aggressive type that often affects younger patients and has a poor prognosis, with limited approved therapies.

"This milestone recognizes the unmet need in the EU and if approved, Enhertu will provide the first targeted treatment option for these patients," Executive Vice President Susan Galbraith said.

Enhertu is being jointly developed and commercialized with Japan's Daiichi Sankyo.

Write to Christian Moess Laursen at christian.moess@wsj.com

(END) Dow Jones Newswires

September 15, 2023 10:36 ET (14:36 GMT)

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