U.S. FDA approves Mirati’s lung cancer drug By Reuters


© Reuters. FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly

(Reuters) – The U.S. Food and Drug Administration on Monday approved Mirati Therapeutics (NASDAQ:) Inc’s lung cancer drug adagrasib, according to the health regulator’s website.

The company’s shares rose more than 11% in extended trading.

Mirati was seeking approval for the drug for treating patients with advanced lung cancer who have stopped responding to other therapies.

Adagrasib, the oral drug 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.

Another KRAS inhibitor, Amgen Inc (NASDAQ:)’s Lumakras is already available to treat patients suffering from advanced lung cancer as a second-line therapy, after an initial therapy fails or stops working.

Third-quarter sales of Lumakras, which was approved last year, totaled $75 million.

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