Mirati's Adagrasib (MRTX849) Receives the US FDA's Breakthrough Therapy Designation for Advanced Non-Small Cell Lung Cancer
Shots:
- The designation is based on the preliminary results from the P-I/II KRYSTAL-01 trial evaluating adagrasib in patients with advanced NSCLC who harbor the KRASG12C mutation following prior systemic therapy
- The studies showed that the therapy has a long half-life- extensive tissue distribution and is well tolerated & showed responses in NSCLC- colorectal cancer- pancreatic cancer- & other solid tumors with KRASG12C mutations
- The company plans to submit NDA for adagrasib in H2’21. The therapy is being evaluated in several clinical trials in combination with other anti-cancer therapies for advanced solid tumors while the studies are ongoing for NSCLC & colorectal cancer
| Ref: Mirati Therapeutics | Image: PR Newswire
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