FDA Greenlights Datroway for EGFR-Mutated Lung Cancer, Expanding ADC’s Reach
Washington D.C. – June 24, 2025 – In a critically important win for patients battling advanced lung cancer, the food and Drug Governance (FDA) today announced the accelerated approval of datopotamab deruxtecan-dlnk (Datroway), developed by Daiichi Sankyo and AstraZeneca, for the treatment of locally-advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer [[1]]. This approval specifically targets individuals who have previously undergone treatment with both EGFR-directed therapies and platinum-based chemotherapy.
Datroway is a trop-2-directed antibody and topoisomerase inhibitor conjugate,representing a cutting-edge approach to cancer treatment. This marks the second approval for this innovative antibody drug conjugate. It initially received approval earlier this year for patients with previously treated unresectable or metastatic HR-positive, HER2-negative breast cancer [[1]].
The decision is based on compelling data from the TROPION-Lung05 and TROPION-Lung01 trials, a pooled subgroup analysis of 114 patients, demonstrating a confirmed overall response rate of 45% and a median duration of response of 6.5 months [[1]], [[1]]. The recommended dosage is 6 mg/kg, capped at 540 mg for patients weighing 90 kg or more, administered intravenously every three weeks until disease progression or unacceptable side effects occur.
Interestingly, AstraZeneca previously withdrew it’s marketing application for Datroway in the EU for non-squamous non-small cell lung cancer, citing feedback from the European Medicines Agency. This decision underscores the rigorous regulatory landscape and the importance of complete clinical data.
What This Means for Patients:
This approval offers a new hope for patients with EGFR-mutated lung cancer who have exhausted other treatment options.Antibody-drug conjugates like Datroway are designed to deliver potent chemotherapy directly to cancer cells, minimizing damage to healthy tissue.Stay tuned to world-today-news.com for ongoing coverage of this developing story and the latest advancements in cancer treatment.
Keywords: FDA, Datroway, datopotamab deruxtecan, lung cancer, non-small cell lung cancer, EGFR, antibody drug conjugate, AstraZeneca, Daiichi Sankyo, cancer treatment, clinical trials, TROPION-Lung05, TROPION-Lung01.
