Currently Enrolling Trials
Krazati is specifically 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.
Krazati is supplied as capsules for oral administration.
- Select patients for treatment of locally advanced or metastatic NSCLC with Krazati based on the presence of KRAS G12C mutation in plasma or tumor specimens. If no mutation is detected in a plasma specimen, test tumor tissue.
- The recommended dosage of Krazati is 600 mg orally twice daily until disease progression or unacceptable toxicity. Take Krazati at the same time every day with or without food. Swallow tablets whole. Do not chew, crush or split tablets.
- If vomiting occurs after taking Krazati, do not take an additional dose. Resume dosing at the
next scheduled time.
If a dose is inadvertently missed, it should be skipped if greater than 4 hours have elapsed from
the expected dosing time. Resume dosing at the next scheduled time.
Mechanism of Action
Krazati (adagrasib) is an irreversible inhibitor of KRAS G12C that covalently binds to the mutant cysteine in KRAS G12C and locks the mutant KRAS protein in its inactive state that prevents downstream signaling without affecting wild-type KRAS protein. Adagrasib inhibits tumor cell growth and viability in cells harboring KRAS G12C mutations and results in tumor regression in KRAS G12C-mutated tumor xenograft models with minimal off-target activity.
Adverse effects associated with the use of Krazati may include, but are not limited to, the following:
- musculoskeletal pain
- renal impairment
- decreased appetite
- laboratory abnormalities, including decreased lymphocytes, decreased hemoglobin, increased alanine aminotransferase, increased aspartate aminotransferase, hypokalemia, hyponatremia, increased lipase, decreased leukocytes, decreased neutrophils and increased alkaline phosphatase
Clinical Trial Results
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.