Shots:

• The approval for the expanded indication is based on P-II QUADRA study assessing Zejula (niraparib) in 463 patients relapsed- high-grade serous epithelial ovarian- fallopian tube- or primary peritoneal cancer prior treated with >3 CT regimen and whose cancer is associated with homologous recombination deficiency (HRD)
• The P-II QUADRA study results demonstrated ORR (24%) with mDOR (8.3 mos.). Additional analyses showed: BRCA+ platinum-sensitive disease- ORR (39%); tBRCA+ platinum-resistant disease- ORR (29%); tBRCA+ platinum-refractory disease- ORR (19%); non-BRCA mut- GIS-positive- platinum-sensitive disease- ORR (20%)
• Zejula (qd) is a PARP inhibitor currently being evaluated in multiple studies as monothx in P-III PRIMA study and FIRST study and as a combination with bevacizumab in P-II OVARIO study. The Myriad myChoice companion diagnostic test was utilized during the P-II QUADRA study

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Ref: Businesswire | Image: GSK