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The median PFS and median overall survival ranged from 7 to 9 and 12 to 22 months, respectively, in the study populations, which have led to the approval of pemigatinib and futibatinib by the FDA and EMA, significantly outperforming second-line chemotherapy results in cross-study comparisons

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[DOI] [PubMed] [Google Scholar] 78.Gonzalez-Burgos G., Lewis D.A

The applicant and commenter further contended that CMS guidance indicates that CMS intended for C1831 to be lumbar-specific