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1 Indications And Usage Zejula Is A Poly(Adp-Ribose) Polymerase (Parp) Inhibitor Indicated: • For The Maintenance Treatment Of Adult Patients With Advanced Epithelial Ovarian, Fallopian Tube, Or Primary Peritoneal Cancer Who Are In A Complete Or Partial Response To First-Line Platinum-Based Chemotherapy. ( 1.1 ) • For The Maintenance Treatment Of Adult Patients With Recurrent Epithelial Ovarian, Fallopian Tube, Or Primary Peritoneal Cancer Who Are In A Complete Or Partial Response To Platinum-Based Chemotherapy. ( 1.2 ) • For The Treatment Of Adult Patients With Advanced Ovarian, Fallopian Tube, Or Primary Peritoneal Cancer Who Have Been Treated With Three Or More Prior Chemotherapy Regimens And Whose Cancer Is Associated With Homologous Recombination Deficiency (Hrd) Positive Status Defined By Either: • A Deleterious Or Suspected Deleterious Brca Mutation, Or • Genomic Instability And Who Have Progressed More Than Six Months After Response To The Last Platinum-Based Chemotherapy. Select Patients For Therapy Based On An Fda-Approved Companion Diagnostic For Zejula. ( 1.3 , 2.1 ) 1.1 First-Line Maintenance Treatment Of Advanced Ovarian Cancer Zejula Is Indicated For The Maintenance Treatment Of Adult Patients With Advanced Epithelial Ovarian, Fallopian Tube, Or Primary Peritoneal Cancer Who Are In A Complete Or Partial Response To First-Line Platinum-Based Chemotherapy. 1.2 Maintenance Treatment Of Recurrent Ovarian Cancer Zejula Is Indicated For The Maintenance Treatment Of Adult Patients With Recurrent Epithelial Ovarian, Fallopian Tube, Or Primary Peritoneal Cancer Who Are In A Complete Or Partial Response To Platinum-Based Chemotherapy. 1.3 Treatment Of Advanced Ovarian Cancer After Three Or More Chemotherapies Zejula Is Indicated For The Treatment Of Adult Patients With Advanced Ovarian, Fallopian Tube, Or Primary Peritoneal Cancer Who Have Been Treated With Three Or More Prior Chemotherapy Regimens And Whose Cancer Is Associated With Homologous Recombination Deficiency (Hrd) Positive Status Defined By Either: • A Deleterious Or Suspected Deleterious Brca Mutation, Or • Genomic Instability And Who Have Progressed More Than Six Months After Response To The Last Platinum-Based Chemotherapy [See Clinical Studies ( 14.3 )]. Select Patients For Therapy Based On An Fda-Approved Companion Diagnostic For Zejula.
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