(Reuters) -The European Medicines Agency’s panel declined to back authorization for Mirati Therapeutics’ drug to treat a type of lung cancer as it did not fulfill the requirements for conditional support.
Mirati said on Friday it disagrees with the EMA’s opinion and intends to request a formal re-examination, but gave no details on the requirements it did not fulfill.
Its drug, adagrasib, approved by the U.S. Food and Drug Administration in December, is designed to target a mutated form of a gene known as KRAS that occurs in about 13% of non-small cell lung cancers, the most common form of the disease, and less frequently in some other solid tumors.
(Reporting by Leroy Leo in Bengaluru; Editing by Shinjini Ganguli)
