Datroway FDA Approval: NSCLC Treatment
The FDA has greenlit datopotamab deruxtecan (Datroway) for adults battling EGFR-mutated non-small cell lung cancer (NSCLC). This accelerated approval offers a new treatment avenue for patients previously treated with EGFR-directed therapy and platinum-based chemotherapy. Clinical trials showcased a compelling 45% overall response rate,indicating a positive impact for certain NSCLC patients. Explore the details of this innovative antibody drug conjugate, jointly developed by Daiichi Sankyo and AstraZeneca. This marks a pivotal moment in advanced NSCLC treatment, offering hope for improved outcomes. News Directory 3 keeps you informed on the latest medical advancements. Discover what’s next as further studies evaluate and expand upon these findings.
FDA Approves datopotamab for EGFR-Mutated Non-Small Cell Lung Cancer
Updated june 24, 2025
The Food and Drug Administration (FDA) has given accelerated approval too datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo) for adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC). This approval is specifically for individuals who have already undergone EGFR-directed therapy and platinum-based chemotherapy.
Datopotamab deruxtecan, a Trop-2-directed antibody and topoisomerase inhibitor conjugate, demonstrated its effectiveness in clinical trials TROPION-Lung05 and TROPION-Lung01. A pooled subgroup of 114 patients showed a 45% overall response rate, with the median duration of response lasting 6.5 months.
The recommended dosage in the trials was 6 mg/kg, up to 540 mg for those weighing 90 kg or more, administered intravenously every three weeks until disease progression or unacceptable toxicity occurred. This marks the second FDA approval for this antibody drug conjugate, jointly developed by Daiichi Sankyo and AstraZeneca. The initial approval came in January for breast cancer.
AstraZeneca previously withdrew its marketing authorization application with the European Medicines Agency for datopotamab deruxtecan to treat non-squamous non-small cell lung cancer, citing feedback from the Committee for medicinal Products for Human Use.
What’s next
The FDA advises reviewing the full prescribing facts for datopotamab deruxtecan on Drugs@FDA, which includes warnings about interstitial lung disease, ocular adverse reactions, stomatitis, and embryo-fetal toxicity. Further studies might potentially be conducted to confirm clinical benefit.