Krazati FDA Approval History
Last updated by Judith Stewart, BPharm on June 24, 2024.
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, Colorectal Cancer
Krazati (adagrasib) is a small-molecule inhibitor of KRAS G12C for the treatment of adult patients with KRAS G12C-mutated non-small cell lung cancer and KRAS G12C-mutated colorectal cancer.
- Krazati is indicated for:
- Non-small cell lung cancer (NSCLC)
As a single agent, for the treatment of adult patients with KRASG12C-mutated locally advanced or metastatic 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 confirmatory trials.
- Colorectal cancer (CRC)
In combination with cetuximab, for the treatment of adult patients with KRASG12C-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.
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 confirmatory trials. - Krazati works as a targeted therapy by inhibiting KRASG12C to suppress tumor growth in patients with KRASG12C-mutated non-small cell lung cancer or colorectal cancer.
- Krazati tablets are taken orally, twice daily, with or without food.
- Warnings and precautions associated with Krazati include gastrointestinal adverse reactions, QTc interval prolongation, hepatotoxicity, and interstitial lung disease/pneumonitis.
- Common adverse reactions:
- as a single agent in NCSLC include nausea, diarrhea, vomiting, fatigue, musculoskeletal pain, hepatotoxicity, renal impairment, edema, dyspnea, and decreased appetite. Common laboratory abnormalities include decreased lymphocytes, decreased hemoglobin, increased alanine aminotransferase, increased aspartate aminotransferase, hypokalemia, hyponatremia, increased lipase, decreased leukocytes, decreased neutrophils and increased alkaline phosphatase.
- in combination with cetuximab in CRC include rash, nausea, diarrhea, vomiting, fatigue, musculoskeletal pain, hepatotoxicity, headache, dry skin, abdominal pain, decreased appetite, edema, anemia, and cough. Common abnormalities include decreased lymphocytes, decreased potassium, decreased magnesium, decreased hemoglobin, increased aspartate aminotransferase, increased lipase, decreased albumin, and increased alanine aminotransferase.
Development timeline for Krazati
Further information
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