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. 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. Third-quarter sales of Lumakras, which was approved last year, totaled $75 million. Mirati Chief Executive David Meek said in a recent interview that the drug is a compelling choice. "I think physicians and patients are going to appreciate having an effective option," he told Reuters, noting that 43% of second-line trial patients responded to adagrasib. Shares of Mirati have fallen about 55% since early this month, after the company's presentation of early data from studies of adagrasib in combination with Merck & Co's (MRK.N) immunotherapy Keytruda as an initial treatment for metastatic NSCLC. The results showed that the combination helped about half of trial participants. But Mirati said it would first move to a trial only in patients with lower levels of the protein targeted by Keytruda, with a high bar of proving superiority over standard of care. Wall Street analysts, initially encouraged by the efficacy and safety findings, questioned Mirati's strategy for future combination studies. "We see a long and challenging path to Phase 3 data ... and possibility for an acquisition is likely off the table for now," BMO Capital Markets analyst Evan Seigerman said in a research note before the approval.
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