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1 Indications And Usage Xpovio Is A Nuclear Export Inhibitor Indicated: In Combination With Dexamethasone For The Treatment Of Adult Patients With Relapsed Or Refractory Multiple Myeloma Who Have Received At Least Four Prior Therapies And Whose Disease Is Refractory To At Least Two Proteasome Inhibitors, At Least Two Immunomodulatory Agents, And An Anti-Cd38 Monoclonal Antibody ( 1.1 ). For The Treatment Of Adult Patients With Relapsed Or Refractory Diffuse Large B-Cell Lymphoma (Dlbcl), Not Otherwise Specified, Including Dlbcl Arising From Follicular Lymphoma, After At Least 2 Lines Of Systemic Therapy ( 1.2 ). These Indications Are Approved Under Accelerated Approval Based On Response Rate. Continued Approval For These Indications May Be Contingent Upon Verification And Description Of Clinical Benefit In Confirmatory Trials ( 1 ). 1.1 Multiple Myeloma Xpovio In Combination With Dexamethasone Is Indicated For The Treatment Of Adult Patients With Relapsed Or Refractory Multiple Myeloma Who Have Received At Least Four Prior Therapies And Whose Disease Is Refractory To At Least Two Proteasome Inhibitors, At Least Two Immunomodulatory Agents, And An Anti-Cd38 Monoclonal Antibody. This Indication Is Approved Under Accelerated Approval Based On Response Rate [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). 1.2 Diffuse Large B-Cell Lymphoma Xpovio Is Indicated For The Treatment Of Adult Patients With Relapsed Or Refractory Diffuse Large B-Cell Lymphoma (Dlbcl), Not Otherwise Specified, Including Dlbcl Arising From Follicular Lymphoma, After At Least 2 Lines Of Systemic Therapy. This Indication Is Approved Under Accelerated Approval Based On Response Rate [See Clinical Studies ( 14.2 )] . Continued Approval For This Indication May Be Contingent Upon Verification And Description Of Clinical Benefit In A Confirmatory Trial(S).
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