FDA approves Krazati (adagrasib) for locally advanced or metastatic non-small cell lung cancer (NSCLC) with a KRASG12C mutation

December 12, 2022 – The FDA has granted accelerated approval to Mirati Therapeutics’ Krazati (adagrasib), an oral KRAS G12C inhibitor, 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.

In 2022, it is estimated that approximately 236,740 adults in the United States will be diagnosed with lung cancer, and NSCLC is thought to account for 82% of those lung cancer diagnoses. An estimated 13%–14% of patients with NSCLC are thought to harbor the KRAS G12C mutation, representing approximately 20,000 to 25,000 people in the United States. According to Amgen, as many as 66% of patients with NSCLC present with advanced or metastatic disease at initial diagnosis.

Krazati has demonstrated a positive benefit-risk profile with accelerated approval based on the Phase 2 registration-enabling cohort of the KRYSTAL-1 study, evaluating Krazati 600 mg capsules administered orally twice daily in 116 patients with KRAS G12C -mutated advanced NSCLC who previously received treatment with a platinum-based regimen and an immune checkpoint inhibitor.

Also on December 12, 2022, the FDA approved Qiagen’s therascreen KRAS RGQ PCR kit and Agilent Technologies’ Resolution ctDx FIRST Assay as companion diagnostics for Krazati.

Krazati will directly compete with Amgen’s Lumakras (sotorasib), which was granted accelerated approval on May 28, 2021, for the same indication.

Mirati has priced Krazati at $240,000 per year; the estimated annual WAC for Lumakras is currently $231,000.

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