Japan endorses the way of Datroway

After much turbulence AstraZeneca/Daiichi Sankyo's datopotamab deruxtecan has crossed the regulatory finish line, becoming the 15th ADC to be approved. So far the nod has come only in Japan, where the MHLW has greenlit the drug, now trademarked Datroway, on the back of the Tropion-Breast01 study in ER-positive, HER2-negative breast cancer. Given that this trial was notable for showing statistical significance for PFS but not OS, the approval is a hopeful sign for the US, where this dato-dxd setting has a late January PDUFA date, and the EU, where a decision could come at the 31 January CHMP day. A bigger problem for dato-dxd is in the more significant setting of lung cancer, where filings for second-line non-squamous NSCLC were pulled first in the US and more recently in the EU, apparently as the regulators refused to accept a subgroup analysis of the Tropion-Lung01 study. The next ADC to face an approval decision looks likely to be AbbVie's cMet-targeting telisotuzumab vedotin, which has an estimated March 2025 PDUFA date for non-squamous NSCLC with cMet protein overexpression.

The world's first 15 approved ADCs

Notes: *Japan only; **China only; ***withdrawn & refiled. Source: OncologyPipeline.