- The US FDA has approved Verzenio + ET for the adjuvant treatment of adult patients with HR+, HER2-, node-positive, EBC at high risk of recurrence and a Ki-67 score of ≥20% as determined by an FDA-approved test
- The approval is based on subgroup analyses of P-III monarchE trial with additional follow-up, conducted post-hoc. In this analysis, Verzenio + ET demonstrated a 37% reduction in the risk of BC recurrence or death vs ET alone for patients with benefits in IDFS event rate of 7.1% @3yrs.
- IDFS events (104 vs 158). Verzenio is the first addition to adjuvant endocrine therapy approved by the FDA in nearly two decades for the treatment of HR+ HER2- EBC
Click here to read full press release/ article | Ref: PR Newswire | Image: Fox Business