AZN : Enhertu Approved In U.S. As First HER2 Directed Therapy For HER2 Mutant Metastatic NSCLC

Daiichi Sankyo and AstraZeneca's (AZN,AZN.L) Enhertu (fam-trastuzumab deruxtecan-nxki) has been approved in the U.S. for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer or NSCLC whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy.

The indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DoR).

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

The accelerated approval by the FDA was based on the results from the DESTINY-Lung02 phase 2 trial, which showed Enhertu reported a confirmed objective response rate of 57.7% in patients with HER2 mutant disease.

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