FDA Approves Datopotamab Deruxtecan for EGFR-Mutated NSCLC

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Key Takeaways

Datopotamab deruxtecan-dlnk received FDA accelerated approval for EGFR-mutated NSCLC after prior EGFR-directed therapy and platinum-based chemotherapy.
Clinical trials showed a 45% overall response rate and a median response duration of 6.5 months in treated patients.
The drug is administered intravenously every three weeks, with warnings for serious adverse events like interstitial lung disease and embryo-fetal toxicity.
Previously approved for HR-positive, HER2-negative metastatic breast cancer, demonstrating improved progression-free survival and objective response rates.

The FDA approved datopotamab deruxtecan-dlnk (Datroway; Daiichi Sankyo) for the treatment of locally advanced or metastatic EGFR-mutated non–small cell lung cancer (NSCLC) after receipt of EGFR-directed therapy and platinum-based chemotherapy.

Today, the FDA granted accelerated approval to datopotamab deruxtecan-dlnk (Datroway; Daiichi Sankyo Inc) for the treatment of adults with locally advanced or metastatic EGFR-mutated non–small cell lung cancer (NSCLC) who have previously received EGFR-directed therapy and platinum-based chemotherapy.¹

The approval was based on efficacy data pooled from 2 clinical trials: TROPION-Lung05 (NCT04484142), a multicenter, single-arm study, and TROPION-Lung01 (NCT04656652), a multicenter, open-label, randomized controlled trial. Together, these studies evaluated 114 patients who had received prior EGFR-directed therapy and platinum-based chemotherapy and were treated with datopotamab deruxtecan at the recommended dose. According to a blinded independent central review using RECIST v1.1 criteria, the confirmed overall response rate was 45% (95% CI, 35%-54%), and the median duration of response was 6.5 months (95% CI, 4.2-8.4), indicating meaningful clinical activity in a difficult-to-treat group of patients.

Datopotamab deruxtecan is administered as an intravenous infusion at a recommended dose of 6 mg/kg every 3 weeks, up to a maximum of 540 mg for patients weighing 90 kg or more. Treatment should continue until disease progression or unacceptable toxicity. The drug’s prescribing information includes warnings and precautions for serious adverse events, including interstitial lung disease/pneumonitis, ocular adverse reactions, stomatitis, and embryo-fetal toxicity.

Earlier this year, datopotamab deruxtecan received FDA approval for the treatment of adult patients with unresectable or metastatic/HR-positive, HER2-negative breast cancer who had received prior endocrine-based therapy and chemotherapy.² The approval was based on results from the phase 3 TROPION-Breast01 (NCT05104866) trial, which demonstrated a statistically significant improvement in progression-free survival (6.9 vs 4.9 months; HR, 0.63; P < .0001) and a higher confirmed objective response rate (36% vs 23%) compared with standard chemotherapy.

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