WILMINGTON, DE — The U.S. Food and Drug Administration (FDA) has granted accelerated approval to DATROWAY® (datopotamab deruxtecan-dlnk) for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have previously received EGFR-directed therapy and platinum-based chemotherapy.
This milestone approval follows Priority Review and Breakthrough Therapy Designation and is based on promising results from the TROPION-Lung05 and TROPION-Lung01 trials. DATROWAY demonstrated an objective response rate (ORR) of 45% with a median duration of response (DoR) of 6.5 months in patients whose cancer had progressed after earlier treatments. Continued approval is contingent on further clinical trials verifying its benefits.
Jacob Sands, MD, Medical Oncology, Dana-Farber Cancer Institute and a TROPION trial investigator, emphasized the significance of the FDA decision. “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.”
DATROWAY is the first TROP2-directed medicine approved specifically for this subset of lung cancer patients. Engineered as a TROP2-directed DXd antibody drug conjugate, its development is being spearheaded by Daiichi Sankyo and AstraZeneca.
Dave Fredrickson, Executive Vice President of Oncology Haematology at AstraZeneca, highlighted the importance of this approval. “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.”
Ken Keller, Global Head of Oncology Business, and President and CEO of Daiichi Sankyo, pointed to DATROWAY’s broader impact. “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 program to further identify where DATROWAY may be used in other types of lung and breast cancer.”
Patient advocacy organizations welcomed this advancement as well. Andrea E. Ferris, President and CEO of LUNGevity, commented, “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.”
The approval of DATROWAY brings new hope to patients facing advanced stages of EGFR-mutated NSCLC, offering an important alternative when all other treatment options have been exhausted. Further trials, including TROPION-Lung14 and TROPION-Lung15, are underway to explore broader applications of DATROWAY in advanced NSCLC treatment settings.
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