The US health regulator approved the QIAGEN therascreen KRAS RGQ PCR kit as well as the Agilent Resolution ctDx FIRST Assay as companion diagnostics for KRAZATI
KRAZATI lung cancer drug. (Credit: Mirati Therapeutics, Inc.)
The US Food and Drug Administration (FDA) has granted accelerated approval to American oncology firm Mirati Therapeutics for KRAZATI (adagrasib) for the treatment of KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC).
The RAS GTPase family inhibitor has been indicated in adult patients, whose condition is determined by an FDA-approved test, and had been subjected to at least one prior systemic therapy.
Mirati Therapeutics CEO David Meek said: “The FDA approval of KRAZATI is a positive development for thousands of patients with KRASG12C mutations, including the approximately 14% of patients with NSCLC adenocarcinomas histology that harbour a KRASG12C mutation.
“Mirati is thrilled to make KRAZATI available in a tablet formulation to patients in the U.S. with advanced NSCLC who have progressed beyond a first-line treatment for the historically difficult-to-treat KRAS mutation.”
The accelerated approval of the RAS GTPase family inhibitor was based on the findings of the phase 2 registration-enabling cohort of the KRYSTAL-1 study featuring 116 patients.
The patients have KRASG12C-mutated advanced NSCLC and previously were on treatment with a platinum-based regimen and an immune checkpoint inhibitor.
According to Mirati Therapeutics, the patients were given KRAZATI 600mg capsules orally twice daily until disease progression or unacceptable toxicity.
The primary efficacy endpoints of the trial were confirmed objective response rate (ORR) and duration of response (DOR). The ORR was shown to be 43% with 80% of patients achieving disease control, while the median DOR was 8.5 months.
In a pooled efficacy analysis, that included phase 1/1b NSCLC and registrational phase 2 NSCLC cohorts from the KRYSTAL-1 trial, the drug candidate delivered an ORR of 44% and a disease control rate of 81%, a median DOR of 12.5 months, and median overall survival of 14.1 months.
Additionally, the US health regulator approved the QIAGEN therascreen KRAS RGQ PCR kit (tissue) as well as the Agilent Resolution ctDx FIRST Assay (plasma) as companion diagnostics (CDx) for KRAZATI.