DATROWAY (datopotamab deruxtecan) is a TROP2-directed antibody-drug conjugate developed by Daiichi Sankyo and co-developed with AstraZeneca, with ongoing global regulatory submissions for breast and lung cancer.

The FDA has granted Priority Review, with a potential decision in the second quarter of 2026, and the review is conducted under Project Orbis for concurrent international evaluation.

Safety findings from the trial remain consistent with prior studies, with ongoing post-market surveillance and regulatory review.

The sBLA is reviewed under Project Orbis, an international collaboration to speed oncology reviews, with additional global regulatory submissions in process for DATROWAY in breast and lung cancer.

Safety signals highlighted encompass interstitial lung disease/pneumonitis, ocular adverse events, stomatitis, and other chemotherapy-related toxicities; labeling includes management guidelines for ILD and ocular effects.

Tropion-Lung12 was terminated due to operational complexity after limited recruitment, in a study combining Datroway with rilvegostomig or rilvegostomig alone versus chemotherapy in ctDNA-positive stage I NSCLC.

Safety data show notable adverse events, including high rates of stomatitis (about 63%), interstitial lung disease/pneumonitis of varying grades, and ocular events (around 36%), with specific management guidance for ILD/pneumonitis, stomatitis, and ocular effects.

Key safety considerations include monitoring for ILD/pneumonitis, ocular adverse events, stomatitis, embryo-fetal toxicity, and reproductive counseling, with detailed guidance on monitoring, dosing adjustments, and contraception.

At ASCO and ESMO, early Datroway data show favorable progression-free and overall survival trends versus Trodelvy in selected cohorts, with HRs varying by trial and mature data pending for some studies.

DATROWAY demonstrated more robust and durable responses in trials enrolling highly aggressive disease, including PD-L1–negative tumors and patients unable to receive immunotherapy.

The MATTERHORN trial of durvalumab-based perioperative therapy reported a 29% reduction in the risk of progression, recurrence, or death, informing EU approval momentum.

Safety findings from TROPION-Breast02 align with prior ADC experience, with manageable adverse effects and no new safety signals, as studies explore combinations and other TROP2-expressing cancers.