(Reuters) -Mirati Therapeutics said on Friday the European Medicines Agency's panel had declined to back authorization for its drug to treat a type of lung cancer, sending the drugmaker's shares down over 11% in early trading.
The EMA said the drugmaker did not fulfill its requirements for conditional support, which Mirati said it disagrees and intends to request a formal re-examination, but gave no details on the requirements it did not fulfill.
The company, however, said it intends to continue supplying the oral drug, adagrasib, under early access in EU member states in alignment with applicable laws and regulations.
The drug, approved by the U.S. Food and Drug Administration in December and sold under brand Krazati, 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.
If the re-examination of Mirati's application is not successful, it could delay the drug's EU launch by more than a year as the company would have to wait for additional data from its confirmatory trial, which is expected in the first half of next year, TD Cowen analyst Tyler Van Buren said in a note.
"At these levels, we believe there are low expectations for Krazati's EU launch," Van Buren said.
The EMA panel's negative opinion will not impact any of Mirati's clinical trials of the drug, the company said.
The drug shrank tumors in 44% of advanced lung cancer patients, data released by the company last year had showed.
However, investors were disappointed when early December data showed the drug combined with Merck & Co's blockbuster immunotherapy, Keytruda, helped only about half of previously untreated metastatic lung cancer patients.