China accepts sNDA for Zejula in ovarian cancer indication

Share on facebook
Share on twitter
Share on linkedin
Share on email
Share on print

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.

YOU MAY BE INTERESTED IN

Secretary of the U.S. Department of Health and Human Services Robert F. Kennedy Jr. appeared before the House Energy and Commerce Subcommittee on Health to defend the HHS fiscal year 2026 budget proposal, and faced criticism from several Democratic lawmakers on what they described as a lack of transparency and scientific rigor in the agency’s recent decisions.

The full-scale Russian invasion of Ukraine has devastated the Ukrainian healthcare infrastructure, disrupting cancer care, halting clinical trials, and compounding long-standing systemic challenges.  Even before the war, Ukraine’s oncology system faced major constraints: Limited access to radiotherapy equipment, outdated chemotherapy supply chains, and workforce shortages. The invasion intensified these issues—cancer hospitals were damaged, warehouses destroyed,...

Patients affected by cancer are increasingly turning to artificial intelligence-powered chatbots, such as ChatGPT and Gemini, for answers to pressing health questions. These tools, available around the clock and free from geographic or scheduling constraints, are appealing when access to medical professionals is limited by financial, language, logistical, or emotional barriers. 

Never miss an issue!

Get alerts for our award-winning coverage in your inbox.

Login