Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that KRAS p.G12C status confers therapeutic sensitivity to Adagrasib in patients with Non-Small Cell Lung Cancer.

The U.S. Food and Drug Administration granted accelerated approval to adagrasib for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer, as determined by an FDA approved test, who have received at least one prior systemic therapy. The product label notes that this indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR), and that continued approval for this indication may be contingent upon verification and description of a clinical benefit in a confirmatory trial(s).

This statement is based on a regulatory approval from the Food and Drug Administration:

KRAZATI is an inhibitor of the RAS GTPase family indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA approved test, who have received at least one prior systemic therapy. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of a clinical benefit in a confirmatory trial(s).

Citation

Mirati Therapeutics, Inc. Krazati (adagrasib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/216340Orig1s000Corrected_lbl.pdf. Revised December 2022. Accessed October 30, 2024. Mirati Therapeutics, Inc. Krazati (adagrasib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/216340Orig1s000Corrected_lbl.pdf. Revised December 2022. Accessed October 6, 2026.

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Contributions

Date Contributor Description
2024-10-30 Van Allen lab Initial access of FDA approvals
2022-12-12 Food and Drug Administration Indication received accelerated approval.