US FDA approves Mirati’s lung cancer drug

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The US Food and Drug Administration on Monday approved Mirati Therapeutics Inc’s lung cancer drug adagrasib, according to the health regulator’s website, sending the company’s shares up more than 8 percent in extended trading.

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

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

Mirati did not immediately respond to a Reuters request for comment over the drug’s pricing and availability.

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.

Earlier this month, Mirati presented early data from studies of adagrasib in combination with Merck & Co’s immunotherapy Keytruda as an initial treatment for metastatic NSCLC.

The results showed the combination helped about half of trial participants. However, Mirati said it would first conduct a pivotal trial only in patients with lower levels of the protein targeted by Keytruda, with a high bar of proving superiority over standard of care.

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