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Amgen Says FDA Completes Review Of SNDA Seeking Full Approval For LUMAKRAS

Por: RTTNews Health December 26, 2023

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Amgen, Inc. () announced Tuesday that the U.S. Food and Drug Administration (FDA) has completed its review of the company's supplemental New Drug Application seeking full approval of LUMAKRAS (sotorasib).The review, which resulted in a Complete Response Letter, was based on the CodeBreaK 200 trial results for the treatment of adults with previously treated locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer... + full article



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