- Health Canada has approved Merck & Co Inc MRK Keytruda (pembrolizumab) for adult patients with high-risk early-stage triple-negative breast cancer (TNBC) setting.
- The approval covers Keytruda combined with chemotherapy as neoadjuvant treatment and then continued as monotherapy as adjuvant treatment after surgery.
- Related: EMA's Advisory Group Backs Approval For Merck's Keytruda In Various Cancer Settings.
- The nod is based on Phase 3 KEYNOTE-522 trial results, demonstrating a statistically significant improvement in patients' event-free survival (EFS) and pathological complete response (pCR) rate.
- Keytruda was first approved in Canada in 2015 and currently has cancer indications.
- Price Action: MRK shares are up 0.07% at $86.97 during the premarket session on Monday's last check.
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