FDA approves further indication for GSK’s Zejula

GSK has received FDA approval for a further indication of its PARP inhibitor Zejula (niraparib) as a fourth-line treatment for women with recurrent ovarian, fallopian tube, or primary peritoneal cancer associated with homologous recombination deficiency (HRD), on the back of results from the QUADRA study involving patients with both BRCA and HRD-positive ovarian cancer which showed significant improvement in progression-free survival of these patients, regardless of their biomarker status. Zejula is also approved as a maintenance therapy for adults with recurrent ovarian, fallopian tube, or primary peritoneal cancers whose tumours have completely or partially responded to platinum-based chemotherapy treatments.
Lead investigator, Dr Kathleen Moore of the University of Oklahoma, said: “Ovarian cancer has a high rate of recurrence, so there is a real need for therapies for women whose cancer has progressed through multiple lines of treatment and who have few or no options left. It’s meaningful to see that Zejula has been approved as a late-line treatment for women including those with and without BRCA mutations.”