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AstraZeneca, Daiichi Sankyo's Enhertu Approved in HER2-Mutated NSCLC in Europe

NEW YORK – The European Commission has approved AstraZeneca and Daiichi Sankyo's Enhertu (trastuzumab deruxtecan) for patients with HER2-mutated advanced non-small cell lung cancer who have already received chemotherapy with or without immunotherapy.

The EC followed the Committee for Medicinal Products for Human Use's recommendation to approve the antibody-drug conjugate based on data from the DESTINY-Lung02 trial, in which there was a 49 percent objective response rate among previously treated patients and a median duration of response of 16.8 months.

The US Food and Drug Administration approved Enhertu in this same lung cancer indication last year based on DESTINY-Lung02 data.

Between 2 percent and 4 percent of NSCLC patients have HER2-mutated tumors.

"Understanding the molecular drivers behind a lung cancer diagnosis is critical, and while there are now targeted options for many patients, those with HER2-mutant non-small cell lung cancer have had few treatment options, none of which have been approved to treat their specific type of lung cancer," Dave Fredrickson, executive VP of AstraZeneca's oncology business unit, said in a statement. "Enhertu is the first HER2-directed option approved for HER2-mutant disease and confirms the relevance of HER2 as a target in lung cancer."

In 2019, AstraZeneca paid Daiichi Sankyo $1.35 billion upfront to codevelop and comarket Enhertu. In the deal, Daiichi Sankyo is also eligible to receive up to $5.5 billion in contingent payments and $1.75 billion in sales-related milestones. Enhertu's approval in the EU in HER2-mutated NSCLC triggers a $75 million milestone payment from AstraZeneca to Daiichi Sankyo. Enhertu sales in most EU territories will be recognized by Daiichi Sankyo.