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 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. DSKYF 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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Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

The approval is based on results from a subgroup analysis of the TROPION-Lung05 Phase 2 trial and supported by data from the TROPION-Lung01 Phase 3 trial.

In TROPION-Lung05 and TROPION-Lung01, Datroway demonstrated a confirmed ORR of 45% in patients with previously treated locally advanced or metastatic EGFR-mutated NSCLC (n=114).

Complete responses were seen in 4.4% of patients, and partial responses were seen in 40%. The median DoR was 6.5 months.

Datroway is a specifically engineered TROP2-directed DXd antibody-drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialized by AstraZeneca and Daiichi Sankyo.

Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: “This first approval of Datroway in lung cancer provides a much-needed option to patients with advanced EGFR-mutated lung cancer whose disease has become resistant to past treatments, regardless of the driving mutation.”

AstraZeneca and Daiichi Sankyo are evaluating Datroway alone and with Tagrisso (osimertinib) in other advanced or metastatic EGFR-mutated NSCLC settings in the TROPION-Lung14 and TROPION-Lung15 Phase III trials.

AstraZeneca released results from three Phase 3 cancer clinical trials at the 2025 American Society of Clinical Oncology Annual Meeting in June.

Enhertu combo showed a median PFS of 40.7 months vs 26.9 months with THP in HER2+ metastatic breast cancer.

Camizestrant combo reduced disease progression risk by 56%, with a median PFS of 16.0 months vs. 9.2 months for standard care.

Price Action: AZN stock is trading higher by 0.88% to $71.26 premarket at the last check on Tuesday.

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