FDA Grants Accelerated Approval To Datroway For Advanced EGFR-Mutant Lung Cancer

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Datroway (datopotamab deruxtecan or Dato-DXd) for adults with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have previously received both EGFR-directed therapies and platinum-based chemotherapy. The decision, which follows a Priority Review and Breakthrough Therapy Designation, is based on results from the TROPION-Lung05 Phase II trial and supported by Phase III TROPION-Lung01 data. The continued approval will hinge on confirmatory evidence of clinical benefit.

Jacob Sands, MD, Medical Oncology, Dana-Farber Cancer Institute and investigator in both trials, said, “Addressing disease progression in patients with advanced EGFR-mutated lung cancer after prior targeted therapy and chemotherapy is very challenging with limited later-line treatment options available. The US approval of datopotamab deruxtecan introduces a novel and needed treatment option to patients with advanced disease.”

Andrea E. Ferris, President and CEO, LUNGevity, said, “For people with advanced EGFR-mutated non-small cell lung cancer whose disease progresses on initial treatments, additional options are limited. Today’s approval of Datroway offers a new treatment option for patients whose disease has progressed following treatment with an EGFR-directed therapy and chemotherapy.”

In clinical studies, Datroway demonstrated a confirmed objective response rate (ORR) of 45% among patients with EGFR-mutated NSCLC who had been heavily pretreated. These results included a complete response in 4.4% of patients and partial responses in 40%, with a median duration of response lasting 6.5 months. The data were reviewed by a blinded independent central review (BICR) panel and reflect outcomes from a subgroup of 114 patients.

Ken Keller, Global Head of Oncology Business, and President and CEO, Daiichi Sankyo, Inc., said, “With today’s accelerated approval, Datroway is now the first TROP2-directed medicine available for certain patients in the US living with lung cancer. We remain committed to our extensive clinical development programme to further identify where Datroway may be used in other types of lung and breast cancer.”

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. We have long supported patients with EGFR-mutated lung cancer and are proud to bring another innovative treatment option to this community.”

Safety findings from a pooled analysis of three trials, TROPION-Lung05, Lung01, and PanTumor01,  revealed a consistent safety profile with no new concerns. Datroway is a TROP2-directed DXd antibody-drug conjugate (ADC), co-developed by Daiichi Sankyo and AstraZeneca. The companies continue to explore its full potential through additional Phase III trials (TROPION-Lung14 and Lung15), including combinations with Tagrisso (osimertinib), targeting broader advanced EGFR-mutated NSCLC populations.