The FDA issued an accelerated approval for Mirati’s Krazati for patients with KRAS-mutated non-small cell lung cancer. The agency also approved a companion diagnostic to identify eligible patients.
The FDA has granted accelerated approval for Mirati Therapeutics’ Krazati (adagrasib) for KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC). The wholesale acquisition cost for Krazati is $237,000 per year, or a monthly cost of $19,750 for 200 mg tablet/180 count bottle, Mirati Therapeutics said in a statement emailed to Formulary Watch. The manufacturer said it would be available in the United States immediately.
Although KRAS G12C is the most common KRAS mutation in NSCLC, patients have had limited options to treat the condition, Mirati said in a news release.
“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 harbor a KRASG12C mutation,” said Mirati CEO David Meek.
The FDA also approved a companion diagnostic, Qiagen’s therascreen KRAS RGQ PCR kit to identify patients eligible for treatment with Krazati. This is the fourth approval for the diagnostic. It is already labeled for used in label for use in NSCLC and colorectal cancer.
The accelerated approval of Krazati based on objective response rate (ORR) and duration of response (DOR). Krazati 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 KRASG12C-mutated advanced NSCLC who previously received treatment with a platinum-based regimen and an immune checkpoint inhibitor.
The trial demonstrated an objective response rate of 43% with 80% of patients achieving disease control. The median duration of response was 8.5 months.
In a pooled efficacy analysis including phase 1/1b NSCLC and registrational phase 2 NSCLC cohorts from the KRYSTAL-1 study evaluating adagrasib as a single agent at 600 mg capsules orally twice daily, Krazati showed an objective response rate of 44% and a disease control rate of 81% based on BICR. Krazati also demonstrated a median duration of response of 12.5 months and median overall survival of 14.1 months.
The most common adverse reactions were nausea, diarrhea, vomiting, fatigue, musculoskeletal pain, hepatotoxicity, renal impairment, edema, dyspnea and decreased appetite. Permanent discontinuation of Krazati because of an adverse reaction occurred in 13% of patients.
“KRAS G12C in NSCLC is an area of high unmet need and new treatment options offer patients and our community new hope for survivorship,” said Bonnie J. Addario, co-founder and board chair of the GO2 Foundation for Lung Cancer. “I’m pleased that patients have options, there’s more awareness of this disease and we are all focused on improving the journeys of people living with KRAS G12C-mutated NSCLC.”
Mirati is launching Mirati & Me, a program to provide patients with support for coverage, access and financial issues.