Mirati Therapeutics’ Krazati (adagrasib) Receives EC’s Approval for Advanced Non-Small Cell Lung Cancer (NSCLC)
Shots:
- The EC has granted conditional marketing approval for Krazati followed by the positive opinion from the CHMP in Nov 2023 valid in all 27 EU member states along with Iceland, Norway and Liechtenstein
- The approval is supported by the data from the P-II (KRYSTAL-1) trial evaluating Krazati (600mg, oral, BID) in participants (n=116) with KRASG12C-mutated advanced NSCLC who were on treatment with a Pt-based regimen and an immune checkpoint inhibitor having the 1EPs of confirmed ORR and DOR
- The data from the P-II demonstrated Krazati’s positive benefit-risk profile as required for the conditional approval
Ref: Mirati | Image: Mirati
Related Posts:- Mirati’s Krazati (adagrasib) Receives the US FDA’s Breakthrough Therapy Designation for the Treatment of Advanced KRAS-Mutated Colorectal Cancer
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Shivani was a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She was covering news related to Product approvals, clinical trial results, and updates. We can be contacted at connect@pharmashots.com.
