FDA approves Mirati’s lung cancer drug

Maryland, Dec. 13 (BNA): The U.S. Food and Drug Administration approved Mirati Therapeutics’ lung cancer drug “Adagrasib,” the company said, sending its shares up more than 8% in extended trade.

According to Reuters, Mirati is approved to treat adult patients with advanced lung cancer according to an FDA-approved test, who have received at least one systemic treatment.

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, the most common form of the disease, and less often in some other solid tumours.

Merati said the drug will be sold under the brand name Krazati at $19,750 for a 200-milligram tablet/180-pill bottle.

Another KRAS inhibitor, Lumakras from Amgen Inc, is already available to treat patients with advanced lung cancer as a second-line treatment, after initial treatment has failed or has stopped working.

Lumakras’ sales in the third quarter, approved last year, totaled $75 million.

The drug is a compelling option, David Meek, CEO of Merati, said in a recent interview.

“I think doctors and patients will appreciate having an effective option,” he told Reuters.


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