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Mirati's Adagrasib (MRTX849) Receives the US FDA's Breakthrough Therapy Designation for Advanced Non-Small Cell Lung Cancer

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Mirati's Adagrasib (MRTX849) Receives the US FDA's Breakthrough Therapy Designation for Advanced Non-Small Cell Lung Cancer

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  • 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

Click here to­ read the full press release 

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