FDA OKs expanded use of Glaxo’s Zejula

The FDA has approved the use of GlaxoSmithKline’s (GSK +1.3%) PARP inhibitor Zejula (niraparib) in patients with advanced  ovarian, fallopian tube, or primary peritoneal cancer patients, who have been treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency-positive (HRD+) status defined by either a deleterious or suspected deleterious BRCA mutation, or genomic instability and who have progressed more than six months after response to the last platinum-based chemotherapy.

This is the first indication for a PARP inhibitor beyond BRCA-positive patients in a late-line setting.

The announcement was made by licensee Zai Lab Limited (ZLAB), owner of commercialization rights in China, Macau and Hong Kong.

Glaxo acquired global rights to Zejula via its $5.1B acquisition of TESARO in January.

https://seekingalpha.com/news/3509121-fda-oks-expanded-use-glaxos-zejula