AstraZeneca : Enhertu Approved In EU For Advanced Non-small Cell Lung Cancer Treatment

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

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

The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use and was based on DESTINY-Lung02 Phase II trial results where AstraZeneca and Daiichi Sankyo's Enhertu demonstrated a confirmed objective response rate of 49% and median duration of response of 16.8 months in previously treated patients.

Following European Commission approval, an amount of $75 million is due from AstraZeneca to Daiichi Sankyo as a milestone payment for this HER2-mutant (HER2m) NSCLC indication.

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