www.fdanews.com/articles/188357-mercks-keytruda-combo-therapy-okd-by-european-commission
Merck’s Keytruda Combo Therapy OK’d by European Commission
September 11, 2018
The European Commission gave the green light for Merck’s Keytruda, granting it EU approval for first-line treatment of lung cancer patients in combination with Pemetrexed and platinum chemotherapy.
The anti-PD-1 therapy is approved for patients with nonsquamous non-small cell lung cancer (NSCLC) in adults whose tumors do not have EGFR or ALK positive mutations.
The Phase 3 Keynote-189 trial showed a significant survival benefit when using Keytruda with chemotherapy as opposed to standard-of-care chemotherapy by itself.