NEW YORK – The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) on Friday conditionally approved Mirati's Krazati (adagrasib) for advanced non-small cell lung cancer patients whose tumors harbor a KRAS G12C mutation and who have already received chemotherapy or anti-PD-1 immune checkpoint inhibitors.
The MHRA's decision is based on data from the NSCLC cohort of the Phase I/II KRYSTAL-1 study in which Mirati is assessing Krazati as a monotherapy and in combination with other treatments in numerous KRAS G12C-mutated cancer indications.
Last year, the US Food and Drug Administration granted accelerated approval to Krazati for the same second-line, KRAS G12C-mutated advanced NSCLC indication. This past summer, however, regulators in Europe went a different route, as the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended against approving Krazati in this indication, arguing that its efficacy is still unclear and that it would not fill an unmet medical need since patients in this population could receive Amgen's KRAS inhibitor Lumakras (sotorasib). Lumakras is approved in the EU as well as in England and the US for KRAS G12C-mutated NSCLC.
Mirati and MHRA did not disclose additional information about the conditional aspects of Krazati's approval before press time.
Once a drug has been licensed by the MHRA, it is reviewed by the National Institute for Health & Care Excellence to gauge if it is cost-effective to provide the treatment to patients within the National Health Service in England. Other bodies do a similar analysis for patients in Wales, Scotland, and Northern Ireland.