GSK’s Zejula (niraparib) Receives FDA’s Approval for Late-line Treatment in Women with Recurrent Ovarian Cancer

 GSK’s Zejula (niraparib) Receives FDA’s Approval for Late-line Treatment in Women with Recurrent Ovarian Cancer

GSK’s Zejula (niraparib) Receives FDA’s Approval for Late-line Treatment in Women with Recurrent Ovarian Cancer

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

Click here to­ read full press release/ article | Ref: Businesswire | Image: Philadelphia Magazine

Vartika Singh

Vartika Singh is a content writer who loves to write research articles and reports at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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