On June 23, the U.S. Food and Drug Administration (FDA) granted accelerated approval to datopotamab deruxtecan-dlnk (Datroway), an antibody-drug conjugate that targets trophoblast cell surface antigen 2 (TROP2), for adults with locally advanced or metastatic EGFR-mutated non–small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy.
TROPION-Lung05 and TROPION-Lung01
Efficacy was evaluated in a pooled subgroup of 114 patients with locally advanced or metastatic EGFR-mutated NSCLC who had received prior treatment with an EGFR-directed therapy and platinum-based chemotherapy and received datopotamab deruxtecan at the recommended dose across two clinical trials: TROPION-Lung05 and TROPION-Lung01. TROPION-Lung05 (ClinicalTrials.gov identifier NCT04484142) was a multicenter, single-arm trial, while TROPION-Lung01 (NCT04656652) was a multicenter, open-label, randomized controlled trial.
The major efficacy outcome measures were confirmed overall response rate and duration of response determined by blinded independent central review per Response Evaluation Criteria in Solid Tumors version 1.1. The overall response rate was 45% (95% confidence interval [CI] = 35%–54%), and median duration of response was 6.5 months (95% CI = 4.2–8.4 months).
The prescribing information for datopotamab deruxtecan includes warnings and precautions for interstitial lung disease/pneumonitis, ocular adverse reactions, stomatitis, and embryofetal toxicity.
Recommended Dosage
The recommended datopotamab deruxtecan dose is 6 mg/kg (up to a maximum of 540 mg for patients ≥ 90 kg), as an intravenous infusion once every 3 weeks until disease progression or unacceptable toxicity.
This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment. This application was granted Priority Review and Breakthrough Therapy designation.
