The China National Medical Products Administration accepted a supplemental New Drug Application for Zejula (niraparib) as a 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.
Zai Lab Ltd. sponsors Zejula.
“We believe Zejula is a potential best-in-class PARP inhibitor due to its compelling efficacy, once-daily dosing and superior pharmacokinetic properties including its ability to cross the blood brain barrier,” Samantha Du, founder and chief executive officer of Zai Lab, said in a statement.
The PRIMA study conducted by GlaxoSmithKline demonstrated that Zejula treatment resulted in a 38% reduction in the risk of disease progression or death in the overall study population when compared to placebo. Zejula also demonstrated benefits in all patient subgroups. For patients whose cancer is associated with homologous recombination deficiency positive status, Zejula treatment resulted in a 57% reduction in the risk of disease progression or death.
FDA previously accepted GSK’s sDNA application for Zejula as first-line maintenance treatment for ovarian cancer based on the PRIMA study.