Adagrasib gets accelerated approval for KRAS G12C-mutated NSCLC

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Jan 2023: Adagrasib (Krazati, Mirati Therapeutics, Inc.), a RAS GTPase family inhibitor, was given accelerated approval by the Food and Drug Administration (FDA) for adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as identified by an FDA-approved test, who have received at least one prior systemic therapy.

As additional companion diagnostics for Krazati, the FDA additionally approved the QIAGEN therascreen KRAS RGQ PCR kit (tissue) and the Agilent Resolution ctDx FIRST Assay (plasma). The tumour tissue should be examined if there was no indication of a mutation in the plasma sample.

The KRYSTAL-1 clinical trial (NCT03785249), which involved patients with locally advanced or metastatic NSCLC with KRAS G12C mutations, served as the foundation for the approval. Efficacy was assessed in 112 individuals whose illness had advanced during or after receiving immune checkpoint inhibitors and platinum-based chemotherapy, either concurrently or sequentially. Patients got adagrasib 600 mg twice daily until their condition progressed or the side effects became intolerable.

The primary efficacy outcome measures were duration of response and confirmed objective response rate (ORR) in accordance with RECIST 1.1, as assessed by a blinded independent central review (DOR). The median DOR was 8.5 months (95% CI: 6.2, 13.8), and the ORR was 43% (95% CI: 34%, 53%).

Diarrhea, nausea, fatigue, vomiting, musculoskeletal pain, hepatotoxicity, renal impairment, dyspnea, edoema, decreased appetite, cough, pneumonia, disorientation, constipation, abdominal pain, and QTc interval prolongation were the most frequent side effects ( 20%). Reduced lymphocytes, increased aspartate aminotransferase, increased sodium, decreased sodium, decreased haemoglobin, increased creatinine, decreased albumin, increased alanine aminotransferase, increased lipase, decreased platelets, decreased magnesium, and decreased potassium were the most prevalent laboratory abnormalities ( 25%).

Adagrasib tablets should be taken orally twice day at a dose of 600 mg until the condition progresses or there is intolerable toxicity.


View full prescribing information for Krazati.


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