NEW YORK – The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday decided against recommending approval for Mirati Therapeutics' Krazati (adagrasib) as a treatment for KRAS G12C-mutated advanced non-small cell lung cancer.
CHMP reasoned that comprehensive data on the drug's activity is not yet available and there are uncertainties about how well it works. The committee also said the medicine did not meet the criteria for conditional marketing authorization, which requires Mirati show that the drug fulfills an unmet need and therefore should be immediately available to patients while the firm collects more data.
NSCLC patients in the EU who have progressed on systemic therapy and have KRAS G12C-mutated tumors have access to Amgen's Lumakras (sotorasib), which was approved in Europe last year.
Mirati said it will request a formal re-examination of CHMP's opinion. In a statement on the CHMP opinion, the firm said it believes Krazati meets conditional marketing authorization requirements "despite there being a currently conditionally approved KRAS G12C inhibitor [in Europe] and that Krazati possesses a differentiated clinical profile."
The company also said it will continue supplying Krazati to eligible European NSCLC patients based on individual requests from healthcare professionals and through an early-access program in EU member states. Ongoing clinical trials for Krazati are also not affected by the CHMP opinion.
The firm said it submitted results from the Phase II KRYSTAL-1 study to regulators for review, which included data from 116 patients with KRAS G12C-mutant advanced NSCLC. The US Food and Drug Administration approved Krazati for this indication in December based on similar data from the KRYSTAL-1 trial.