Kadcyla (T-DM1) in HER2+ mBC: Label Update on LVEF following a post approval commitment - based on RWD

Roche/Genentech had a regulatory post-approval commitment to evaluate cardiac safety of Kadcyla in metastatic breast cancer patients with low left ventricular ejection fraction (LVEF less than 50%), a population excluded from the original clinical trials. When prospective disease-registry recruitment proved insufficient, they partnered with Flatiron Health on a retrospective EHR-based study using modular technology-enabled abstraction, identifying 67 patients with LVEF between 40-50% out of roughly 2,000 Kadcyla-treated patients in the database. This population was found to be rare, mostly with pre-existing cardiac history, with no drastic increase in cardiac risk observed, supporting label updates for Kadcyla in Europe, the US, and Canada.

Flatiron Health is a Roche-owned company supplying EHR-derived oncology real-world data, captured at the source through its own OncoEMR software.

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