Mirati’s KRAS Inhibitor Krazi Fails to Make It in Europe

Mirati Therapeutics has learned the hard way that a clearance from the U.S. Food and Drug Administration is not indicative of acceptance overseas. This is a lesson that the firm learned after European authorities rejected its flagship KRAS inhibitor, Krazati.  

Mirati has disclosed that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency had rejected the firm’s request for conditional marketing approval for Krazati (also referred to as adagrasib) for the treatment of those suffering from KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC). Mirati claimed in a press statement that it objects to the ruling and plans to submit a request for a formal re-examination.

KRAS was once believed to be an undruggable target, but there are currently two drugs that have been authorized by the FDA that are competing in what might be an enormous cancer market in the country. Mirati joined the battle with Krazati, the biotech’s first commercial medication, in December, shortly after Amgen received expedited approval for its competitor KRAS inhibitor Lumakras in May 2021.

Mirati’s medication recently stunned industry observers by producing $6.3 million in sales during its first full quarter on the market, whereas Amgen’s drug had a sequential sales loss in the U.S. during the first quarter of this year.

As far as the European Union rebuff goes, Mirati stated that CHMP considers Krazati to have a strong risk-benefit balance; nonetheless, it does not meet specific standards to receive conditional marketing approval. 

In an indirect reference to Amgen, Mirati noted that it believes Krazati meets the Conditional Marketing Authorization standards despite the fact that there is already a KRAS G12C inhibitor that has been conditionally authorized, and that Krazati exhibits a distinct clinical record. 

The biotechnology company highlighted some distinguishing characteristics, such as Krazati’s safety profile, its potential action in the central nervous system, and how it’s compatible with other drugs that combat cancer.

David Meek, Mirati CEO, remarked that the company fully believes that adagrasib is a beacon of hope for patients living in Europe. He added, “We will continue to work closely with the EMA and the CHMP to bring adagrasib to eligible patients. We are committed to delivering therapeutic options for patients living with KRAS G12C-mutated NSCLC in the EU, as we have in the United States following the Accelerated Approval of KRAZATI in December 2022.”

The EU application that Mirati submitted makes use of data from the phase 2  group of the Krystal-1 investigation. In this experiment, Krazati was administered at a dosage of 600 mg twice daily to 116 patients who had KRAS G12C-mutated NSCLC and had received prior treatment. According to the research, the drug was successful in reducing the size of tumors in 43% of participants.

Strangely, Mirati claims that it is already providing Krazati to some European patients after receiving particular requests for it from medical experts. In spite of the rebuke from the EMA, the company has every intention of continuing to distribute Krazati under early access throughout the member states of the EU.

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