AstraZeneca's Enhertu Recommended For Approval In EU For Advanced Non-small Cell Lung Cancer

(RTTNews) - AstraZeneca Plc. (AZN.L, AZN) and Daiichi Sankyo's (DSKYF.PK) Enhertu has been recommended for approval in the European Union by the Committee for Medicinal Products for Human Use or CHMP as monotherapy for the treatment of adult patients with advanced non-small cell lung cancer whose tumours have an activating HER2 (ERBB2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.

The recommendation was based on DESTINY-Lung02 phase II trial results which showed Enhertu achieved strong and durable tumour responses in previously treated HER2-mutant disease. Enhertu showed a confirmed objective response rate of 49% and median duration of response of 16.8 months.

The safety profile of Enhertu in the DESTINY-Lung02 trial was consistent with previous clinical trials with no new safety signals identified.

HER2-mutant non-small cell lung cancer is an aggressive form of lung cancer that often affects younger patients and has a poor prognosis, with limited approved therapies.

Enhertu is a specifically engineered HER2-directed antibody drug conjugate being jointly developed and commercialized by AstraZeneca and Daiichi Sankyo.

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