FDA Grants Accelerated Approval to Datopotamab Deruxtecan for EGFR-Positive NSCLC

The FDA has granted accelerated approval to datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo, Inc) 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, according to an announcement from the agency today.

Datopotamab deruxtecan was evaluated in TROPION-Lung05, a multicenter, single-arm trial, and TROPION-Lung01, a multicenter, open-label, randomized controlled trial. The 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 the clinical trials, TROPION-Lung05 and TROPION-Lung01.

The major efficacy outcome measures were the confirmed overall response rate (ORR) and duration of response (DOR), with an ORR of 45% (95% CI, 35%-54%) and a median DOR of 6.5 months (95% CI, 4.2-8.4). The recommended dose of datopotamab deruxtecan is 6 mg/kg (up to a maximum of 540 mg for patients weighing 90 kg or more), as an IV infusion once every 3 weeks, until disease progression or unacceptable toxicity occurs, according to the FDA.

The prescribing information for datopotamab deruxtecan includes warnings and precautions related to interstitial lung disease/pneumonitis, stomatitis, adverse ocular reactions, and embryo-fetal toxicity, officials said.

This application was previously granted priority review and breakthrough therapy designation, according to the FDA.