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Mirati announces New Therapy Targeting KRAS G12C Mutation for Metastatic NSCLC.

On December 12, 2022, the US Food and Drug Administration (FDA) approved KRAZATI® (adagrasib) 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).1


The National Drug Code (NDC) for KRAZATI is as follows:

  •  80739-812-18: 200 mg, bottle containing 180 tablets1


The recommended dosage of KRAZATI is 600 mg orally twice daily.1


Please see Full Prescribing Information.





Gastrointestinal Adverse Reactions

∙     KRAZATI can cause severe gastrointestinal adverse reactions

∙     Monitor and manage patients using supportive care, including

      antidiarrheals, antiemetics, or fluid replacement, as indicated.

      Withhold, reduce the dose, or permanently discontinue KRAZATI

      based on severity


QTc Interval Prolongation

∙     KRAZATI can cause QTc interval prolongation, which can

      increase the risk for ventricular tachyarrhythmias (eg, torsades

      de pointes) or sudden death 

∙     Avoid concomitant use of KRAZATI with other products with a

      known potential to prolong the QTc interval. Avoid use of

      KRAZATI in patients with congenital long QT syndrome and in

      patients with concurrent QTc prolongation

∙     Monitor ECGs and electrolytes prior to starting KRAZATI, during

      concomitant use, and as clinically indicated in patients with

      congestive heart failure, bradyarrhythmias, electrolyte

      abnormalities, and in patients who are taking medications that

      are known to prolong the QT interval. Withhold, reduce the dose,

      or permanently discontinue KRAZATI, depending on severity



∙     KRAZATI can cause hepatotoxicity, which may lead to drug-

      induced liver injury and hepatitis

∙     Monitor liver laboratory tests (AST, ALT, alkaline phosphatase,

      and total bilirubin) prior to the start of KRAZATI, and monthly for

      3 months or as clinically indicated, with more frequent testing in

      patients who develop transaminase elevations. Reduce the dose,

      withhold, or permanently discontinue KRAZATI based on severity


Interstitial Lung Disease/Pneumonitis

∙     KRAZATI can cause interstitial lung disease (ILD)/pneumonitis,

      which can be fatal        

∙     Monitor patients for new or worsening respiratory symptoms

      indicative of ILD/pneumonitis (eg, dyspnea, cough, fever) during

      treatment with KRAZATI       

∙     Withhold KRAZATI in patients with suspected ILD/pneumonitis

      and permanently discontinue KRAZATI if no other potential

      causes of ILD/pneumonitis are identified      


Adverse Reactions

∙     The most common adverse reactions in NSCLC patients (≥20%)

      are diarrhea, nausea, fatigue, vomiting, musculoskeletal pain,

      hepatotoxicity, renal impairment, dyspnea, edema, decreased

      appetite, cough, pneumonia, dizziness, constipation, abdominal

      pain, and QTc interval prolongation


Females and Males of Reproductive Potential

∙     Infertility: Based on findings from animal studies, KRAZATI may

      impair fertility in females and males of reproductive potential


Please see Full Prescribing Information.

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