STAT+: European regulatory panel weighs against approval of Mirati’s KRAS-targeted lung cancer drug
A European regulatory panel reviewing a lung cancer drug made by Mirati Therapeutics has recommended against its approval, the company said Friday.
Mirati said it will appeal the negative opinion of the drug, called Krazati, issued by a committee of the European Medicines Agency that met this week. But for now, the adverse decision is likely to be adopted by European regulators and prevent the company from marketing the drug in Europe.
Krazati is a pill that works by blocking a specific type of KRAS alteration called G12C, found in approximately 13% of lung tumors.
