WILMINGTON, Del.– The U.S. Food and Drug Administration has granted accelerated approval to DATROWAY (datopotamab deruxtecan-dlnk) for the treatment of adults with advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have previously received both EGFR-targeted therapy and platinum-based chemotherapy.
The drug becomes the first TROP2-directed therapy approved in the United States for lung cancer, offering a new option for patients whose disease has progressed following earlier treatments.
The FDA’s decision is based on data from the TROPION-Lung05 Phase II trial, supported by additional results from the TROPION-Lung01 Phase III study. The approval is contingent upon further clinical benefit confirmation through ongoing studies.
“Treating patients with advanced EGFR-mutated lung cancer after prior therapies is extremely challenging,” said Dr. Jacob Sands, medical oncologist at Dana-Farber Cancer Institute and investigator in both trials. “This approval provides an important and much-needed new option.”
In clinical trials, DATROWAY showed an objective response rate (ORR) of 45 percent in patients previously treated for advanced EGFR-mutated NSCLC. Among the 114 participants in the analysis, 4.4 percent experienced complete responses and 40 percent achieved partial responses. The median duration of response was 6.5 months. Safety data from over 120 patients across three trials indicated a consistent safety profile, with no new concerns identified.
DATROWAY is an engineered TROP2-directed DXd antibody-drug conjugate developed by Daiichi Sankyo and co-commercialized with AstraZeneca. It is designed to deliver cytotoxic agents directly to tumor cells expressing the TROP2 protein, which is commonly found in certain types of lung cancer.
“This first approval of DATROWAY in lung cancer provides a new and innovative treatment for patients who have exhausted other options,” said Dave Fredrickson, executive vice president of AstraZeneca’s Oncology Haematology Business Unit. “It reflects our long-standing commitment to supporting the EGFR-mutated lung cancer community.”
“With this approval, DATROWAY becomes the first TROP2-directed medicine available for certain lung cancer patients in the U.S.,” said Ken Keller, president and CEO of Daiichi Sankyo, Inc. “We are continuing our extensive clinical development program to explore its potential in other lung and breast cancer types.”
Patient advocacy groups have also welcomed the approval. Andrea Ferris, president and CEO of LUNGevity, said the decision offers renewed hope to patients with limited treatment options. “For those whose disease progresses after standard therapies, this is a vital new option.”
AstraZeneca and Daiichi Sankyo are continuing to study DATROWAY in combination with TAGRISSO (osimertinib) and as a monotherapy in other advanced or metastatic EGFR-mutated NSCLC settings through ongoing Phase III trials, TROPION-Lung14 and TROPION-Lung15.
