EU Regulator Declines To Support Mirati’s Lung Cancer Drug – The drug, approved by the U.S. Food and Drug Administration in December and sold under the brand Krazati, is designed to target a mutated form of a gene known as KRAS that occurs in about 13 percent of non-small cell lung cancers, the most common form of the disease, and less frequently in some other solid tumors.
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.
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 the brand Krazati, is designed to target a mutated form of a gene known as KRAS that occurs in about 13 percent of non-small cell lung cancers, the most common form of the disease, and less frequently in some other solid tumors.
EU Regulator Declines To Support Mirati’s Lung Cancer Drug
The EMA panel’s negative opinion will not impact any of Mirati’s clinical trials of the drug, the company said. It is currently enrolling patients in a confirmatory late-stage trial, data for which is expected in the first half of next year, Mirati said.
The drug shrank tumors in 44 percent of advanced lung cancer patients, data released by the company last year had shown.
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.
SVB Securities had then said the 49 percent overall response rate seen with the drug combination was similar to that from a combination of chemotherapy and Keytruda.
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