FDA Approves AstraZeneca And Daiichi Sankyo's Datroway For EGFR-Mutated Lung Cancer

The Food and Drug Administration (FDA) on Monday approved AstraZeneca Plc’s (NASDAQ:AZN) Datroway (datopotamab deruxtecan or Dato-DXd) for adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-Directed therapy and platinum-based chemotherapy.

Following the U.S. approval, $45 million is due from AstraZeneca to Daiichi Sankyo Co., Ltd. (OTC:DSKYF) (OTC:DSNKY) as a milestone payment for the locally advanced or metastatic EGFR-mutated NSCLC indication. Daiichi Sankyo recognizes Datroway’s sales in the U.S.

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

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