The US Food and Drug Administration (FDA) has granted accelerated approval for Mirati Therapeutics’ Krazati (adagrasib) as a targeted therapy option to treat KRASG12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults.

The therapy is indicated for such patients who have previously received a minimum of one systemic therapy.

Krazati is an oral small-molecule KRASG12C inhibitor with a positive benefit-risk profile.

The accelerated approval is based on the data from Phase II registration-enabling cohort of the KRYSTAL-1 clinical trial of 600mg oral dose of Krazati given twice a day.

It enrolled 116 subjects with KRASG12C-mutated advanced NSCLC who had priorly received treatment with a platinum-based regimen and an immune checkpoint inhibitor.

The objective response rate (ORR) and duration of response (DOR) as analysed by blinded independent central review (BICR) as per the response evaluation criteria in solid tumours (RECIST v1.1) were the trial’s primary efficacy endpoints.

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According to the findings, an ORR of 43% was reported, with 80% of the subjects attaining disease control.

Additionally, the median DOR was found to be 8.5 months.

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 US with advanced NSCLC who have progressed beyond a first-line treatment for the historically difficult-to-treat KRAS mutation.

“We look forward to continuing to advance our Krazati development programme including several monotherapy and combination studies in KRASG12C-mutated solid tumours.”

In November this year, the company entered a clinical trial partnership and supply agreement with Incyte to analyse INCB99280 plus adagrasib in KRASG12C-mutated solid tumour patients.