Eli Lilly and Co. said the U.S. Food and Drug Administration approved its Alimta tumor-fighting medicine for a new use in a lung cancer combination treatment.
Alimta now may be marketed to patients in combination with carboplatin chemotherapy and Merck & Co. Inc.'s Keytruda for the initial treatment of nonsquamous non-small cell lung cancer, or NSCLC, regardless of patients' levels of a protein known as PD-L1 that is found on the surface of cancer cells.
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The regulator granted accelerated approval based on tumor response rate and progression-free survival, a measure of how long patients live without their disease worsening. Alimta's approval for this specific use may depend on the results of confirmatory trials, Indianapolis-based Lilly said in a statement.
Merck won accelerated approval for a combination of Keytruda with Alimta and carboplatin in May 2017 for the initial treatment of nonsquamous NSCLC that has spread. That approved use is now included in Alimta's prescribing information and is based on data from Merck's Keynote-021 study.
Alimta was first approved in 2004 and has FDA clearance for use in different types of NSCLC patients.

