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Krazati FDA Approval History

Last updated by Judith Stewart, BPharm on Dec 27, 2022.

FDA Approved: Yes (First approved December 12, 2022)
Brand name: Krazati
Generic name: adagrasib
Dosage form: Tablets
Company: Mirati Therapeutics, Inc.
Treatment for: Non-Small Cell Lung Cancer

Krazati (adagrasib) is a small-molecule inhibitor of KRAS G12C for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC).

Development timeline for Krazati

Dec 12, 2022Approval FDA Approves Krazati (adagrasib) for Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) with a KRASG12C Mutation
May 26, 2022Investigational Adagrasib Delivers Positive Results in Registration-Enabling Study of Patients with KRASG12C-Mutated Advanced Non-Small Cell Lung Cancer
Feb 15, 2022U.S. Food and Drug Administration (FDA) Accepts Mirati Therapeutics' New Drug Application for Adagrasib as Treatment of Previously Treated KRASG12C-Mutated Non-Small Cell Lung Cancer

Further information

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