Datroway Gains Second FDA Nod With NSCLC Approval

The FDA has granted accelerated approval to datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo) for certain patients with locally-advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer.

Specifically, the Trop-2-directed antibody and topoisomerase inhibitor conjugate

was approved for adults previously treated with an EGFR-directed therapy and platinum-based chemotherapy, according to the approval notice. 

The approval marks the second for the antibody drug conjugate, which was discovered by Daiichi Sankyo and is being jointly developed with AstraZeneca. Initial approval was granted in January for previously treated patients with unresectable or metastatic HR-positive, HER2-negative breast cancer, as reported by Medscape.

The new approval was based on efficacy demonstrated in a pooled subgroup of 114 patients treated with datopotamab deruxtecan in the TROPION-Lung05 and TROPION-Lung01 trials. The confirmed overall response rate among the patients was 45%, and the median duration of response was 6.5 months.

Patients in the two trials were treated at the recommended dose of 6 mg/kg, up to a maximum of 540 mg for patients weighing 90 kg or more, given as an intravenous infusion once every 3 weeks until disease progression or unacceptable toxicity.

Last year, AstraZeneca voluntarily withdrew its marketing authorization application with the EU’s medicines regulator for the antibody drug conjugate for the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer based on the TROPION-Lung01 phase 3 trial.

The decision “was informed by feedback from the Committee for Medicinal Products for Human Use of the European Medicines Agency,” the drug company said in a press release.

Reuters previously reported that data from TROPION-Lung01 “has repeatedly knocked [AstraZeneca’s] shares, most recently in September when results showed that the drug did not significantly improve overall survival results for patients.”

Full prescribing information for datopotamab deruxtecan, which will be posted on Drugs@FDA, includes warnings and precautions for interstitial lung disease/pneumonitis, ocular adverse reactions, stomatitis, and embryo-fetal toxicity. 

Sharon Worcester, MA, is an award-winning medical journalist based in Birmingham, Alabama, writing for Medscape, MDedge, and other affiliate sites. She currently covers oncology, but she has also written on a variety of other medical specialties and healthcare topics. She can be reached at [email protected] or on X: @SW_MedReporter.