The U.S. Food and Drug Administration (FDA) has granted accelerated approval for Datroway (datopotamab deruxtecan or Dato-DXd) for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have previously received EGFR-targeted therapy and platinum-based chemotherapy.
This marks the first FDA approval of a TROP2-directed antibody-drug conjugate (ADC) for this patient population, offering a much-needed treatment option for individuals with limited alternatives after standard therapies fail.
The approval is based on objective response rate (ORR) and duration of response (DoR) data from the TROPION-Lung05 Phase II trial, supported by findings from the TROPION-Lung01 Phase III trial. In the subgroup of previously treated patients with EGFR-mutated NSCLC, Datroway showed a confirmed ORR of 45%, with complete responses in 4.4% and partial responses in 40% of patients. The median DoR was 6.5 months.
“This approval brings a novel and much-needed treatment option to patients with advanced disease,” said Dr. Jacob Sands, Medical Oncologist at Dana-Farber Cancer Institute and investigator in both TROPION trials. “Patients whose cancers progress after EGFR-targeted therapies and chemotherapy have few effective treatments available.”
The FDA granted Datroway Breakthrough Therapy Designation and Priority Review, reflecting its potential to address a significant unmet need. Continued approval may be contingent upon further clinical benefit shown in confirmatory trials.
“This is a major milestone for patients whose disease has become resistant to current treatments,” said Dave Fredrickson, Executive Vice President, Oncology at AstraZeneca. “We are proud to deliver another option to the EGFR-mutated lung cancer community.”
Ken Keller, President and CEO of Daiichi Sankyo, emphasized the broader potential of Datroway. “It’s the first TROP2-directed therapy approved in the U.S. for lung cancer, and we’re committed to further exploring its use in lung and breast cancers through ongoing trials.”
Patient advocacy leaders also welcomed the news. “For people whose cancer progresses after initial treatments, options have been extremely limited,” said Andrea Ferris, CEO of LUNGevity. “Datroway gives new hope to those living with this aggressive form of lung cancer.”
Datroway is jointly developed and commercialized by AstraZeneca and Daiichi Sankyo. The companies are actively studying its use in combination with Tagrisso (osimertinib) and in other advanced EGFR-mutant NSCLC settings through the TROPION-Lung14 and TROPION-Lung15 Phase III trials.