GSK’s Zejula Wins First-Line Ovarian Cancer Use

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

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.

The FDA approval for Zejula as a first-line treatment in ovarian cancer was announced 29 April and is based on data from the PRIMA study, a double-blind, randomized Phase III...

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