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# Mirati Gets Accelerated OK for Lung Cancer Drug
- URL: https://www.fdaweb.com/mirati-gets-accelerated-ok-for-lung-cancer-drug/
- Published: 2022-12-12T12:00:00.000Z
- Updated: 2026-09-14T18:09:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153378

FDA has granted accelerated approval to Mirati Therapeutics on its NDA for Krazati (adagrasib), a RAS GTPase family inhibitor for treating adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer. This is determined by simultaneously approved companion diagnostics — Qiagen’s therascreen KRAS RGQ PCR kit (tissue) and Agilent’s Resolution ctDx FIRST Assay (plasma).

Krazati’s approval was based on data from KRYSTAL-1, a multicenter, single-arm, open-label clinical trial in 112 patients whose disease has progressed on or after platinum-based chemotherapy and an immune checkpoint inhibitor, given either concurrently or sequentially, according to an [FDA release](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-adagrasib-kras-g12c-mutated-nsclc?utm%5Fmedium=email&utm%5Fsource=govdelivery). Data showed that the confirmed objective response rate was 43% and median duration of response DOR was 8.5 months.

FDA says that the most common adverse reactions seen in more than 20% of patients were diarrhea, nausea, fatigue, vomiting, musculoskeletal pain, hepatotoxicity, renal impairment, dyspnea, edema, decreased appetite, cough, pneumonia, dizziness, constipation, abdominal pain, and QTc interval prolongation.