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1 Indications And Usage Pemazyre Is Indicated For The Treatment Of Adults With Previously Treated, Unresectable Locally Advanced Or Metastatic Cholangiocarcinoma With A Fibroblast Growth Factor Receptor 2 (Fgfr2) Fusion Or Other Rearrangement As Detected By An Fda-Approved Test [See Dosage And Administration ( 2.1 )] . This Indication Is Approved Under Accelerated Approval Based On Overall Response Rate And Duration Of Response [See Clinical Studies ( 14.1 )]. Continued Approval For This Indication May Be Contingent Upon Verification And Description Of Clinical Benefit In A Confirmatory Trial(S). Pemazyre Is A Kinase Inhibitor Indicated For The Treatment Of Adults With Previously Treated, Unresectable Locally Advanced Or Metastatic Cholangiocarcinoma With A Fibroblast Growth Factor Receptor 2 (Fgfr2) Fusion Or Other Rearrangement As Detected By An Fda-Approved Test. ( 1 , 2.1 ) This Indication Is Approved Under Accelerated Approval Based On Overall Response Rate And Duration Of Response. Continued Approval For This Indication May Be Contingent Upon Verification And Description Of Clinical Benefit In A Confirmatory Trial(S). ( 1 , 2.1 )
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