Krazati (adagrasib) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration. Deprecated

Citation

Mirati Therapeutics, Inc. Krazati (adagrasib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216340s005lbl.pdf. Revised June 2024. Accessed October 6, 2026.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication

Statements

KRAZATI is an inhibitor of the RAS GTPase family indicated in combination with cetuximab for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic CRC, as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. These indications are approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR). Continued approval for these indications may be contingent upon verification and description of a clinical benefit in confirmatory trials.

1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations	Biomarkers	Cancer types	Therapies
FDA (1)	KRAS p.G12C	Colorectal Adenocarcinoma	Adagrasib, Cetuximab