U.S. FDA Approves Mirati’s Lung Cancer Drug

The U.S. Food and Drug Administration approved Mirati Therapeutics Inc’s lung cancer drug adagrasib, the company said on Monday, sending its shares up more than 8% in extended trading.

Mirati’s drug has been approved for treating adult patients with advanced lung cancer as determined by an FDA-approved test, who have received at least one prior systemic therapy.

Adagrasib, an 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 (NSCLC), the most common form of the disease, and less frequently in some other solid tumors.

Mirati said the drug will be sold under the brand name Krazati at a price of $19,750 for a 200 milligram tablet/180 count bottle.

Another KRAS inhibitor, Amgen Inc’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.