1. Scrip
  2. >>R&D
  3. >>Clinical Trials

GSK’s Zejula Wins First-Line Ovarian Cancer Use

FDA Extension Is PARP Inhibitor’s Third Indication In That Disease

 
• By Sten Stovall

Winning an expanded US FDA indication for Zejula as a first-line ovarian cancer treatment further vindicates GSK’s hefty purchase price for Tesaro and sets the scene for more therapeutic extensions for the PARP inhibitor, oncology R&D chief Axel Hoos told Scrip.

Niraparib_Molecule
Oral, once-daily PARP inhibitor niraparib is being evaluated in multiple pivotal trials. • Source: Shutterstock

The US Food and Drug Administration has approved GlaxoSmithKline PLC’s Zejula (niraparib) as a first line maintenance treatment of women with ovarian cancer, bringing the PARP inhibitor – which GSK acquired last year by buying Tesaro for $5.1bn – its third indication for the disease. Axel Hoos, GSK’s head of oncology R&D, told Scrip the oral, once-daily therapy would soon enter studies in lung and breast cancer.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Clinical Trials

Seven Up For Sanofi and Regeneron With Dupixent CSU Approval

 
• By Kevin Grogan

The IL-4/IL-13 inhibitor has been approved in the US as the first targeted therapy in over a decade for chronic itching.

In Brief: BriaCell’s Breast Cancer Cell Therapy Boosts Survival In Phase II

 
• By Sushmita Panda

BriaCell announced its cell therapy Bria-IMT plus checkpoint inhibitors bested Gilead’s Trodelvy in a Phase II trial in HR+ breast cancer; a Phase III trial is enrolling.

Henlius In David Versus Goliath Race With Pfizer For First PD-L1 ADC

 
• By Dexter Jie Yan

While Henlius Biotech’s PD-L1-targeting antibody-drug conjugate HLX43 is struggling to catch up with Pfizer’s PF-08046054, the global frontrunner in the space, a key differentiation of the China-originated asset could lie in PD-L1-negative patients.

Camzyos nHCM Failure Could Open Door To Threat From Cytokinetics’ Aficamten

 
• By Alaric DeArment

BMS’s Phase III ODYSSEY-HCM study did not show statistical significance for either of its two primary endpoints.

More from R&D

Henlius In David Versus Goliath Race With Pfizer For First PD-L1 ADC

 
• By Dexter Jie Yan

While Henlius Biotech’s PD-L1-targeting antibody-drug conjugate HLX43 is struggling to catch up with Pfizer’s PF-08046054, the global frontrunner in the space, a key differentiation of the China-originated asset could lie in PD-L1-negative patients.

AstraZeneca Logs Japan Growth Despite Price Cuts

 
• By Lisa Takagi

AstraZeneca logs growth in Japan despite a big reimbursement price cut for one of its top sellers and expects 40 approvals in the country over the next six years.

Camzyos nHCM Failure Could Open Door To Threat From Cytokinetics’ Aficamten

 
• By Alaric DeArment

BMS’s Phase III ODYSSEY-HCM study did not show statistical significance for either of its two primary endpoints.