New EU approval for GSK's Zejula

GlaxoSmithKline's once-daily PARP inhibitor Zejula (niraparib) has been approved by the European Commission for first-line monotherapy maintenance treatment for adults with advanced ovarian cancer.

Specifically, the indication covers the drug's use for patients with advanced epithelial (FIGO Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response following platinum-based chemotherapy.

The approval makes Zejula the only PARP inhibitor approved in the region for use as a monotherapy for patients with advanced ovarian cancer, regardless of their biomarker status.

“Over 65,000 women in Europe are diagnosed with ovarian cancer each year. This approval of Zejula means that many more women will have the option to receive this innovative medicine earlier, potentially extending the time they may spend without their devastating cancer progressing,” noted Dr Hal Barron, chief scientific officer and president R&D, GSK.

“Until now, only women with BRCA-mutant (BRCAm) ovarian cancer, representing just 20% of patients with advanced ovarian cancer, were eligible to be treated with a PARP inhibitor as monotherapy in the first-line maintenance setting,” explained Dr Antonio Gonzalez-Martin, co-director, Department of Medical Oncology, Clinica Universidad de Navarra, Spain, and primary investigator for the PRIMA trial. “Expanding the potential use of Zejula, regardless of biomarker status, is an important step forward in treating this challenging cancer.”

Data from the PRIMA study show significantly improved progression-free survival (PFS) for patients treated with Zejula, regardless of biomarker status.

In the homologous recombination deficient (HRd) population, Zejula resulted in a 57% reduction in the risk of disease progression or death versus placebo and a 38% reduction in the risk of disease progression or death vs placebo in the overall population. In addition, there was a 60% reduction in risk of progression in those with BRCA mutation tumours.

Nucala filings

GSK also announced that EU regulators have accepted marketing applications for Nucala (mepolizumab) for three additional eosinophil-driven diseases.

The submissions based on positive data from pivotal studies in hypereosinophilic syndrome, chronic rhinosinusitis with nasal polyps and eosinophilic granulomatosis with polyangiitis.

Nucala is currently approved for use in Europe as an add-on treatment for patients with severe eosinophilic asthma. If the new applications are approved, the drug will be the only treatment indicated for use in four eosinophil-driven diseases in Europe, the first biologic approved for HES and the first treatment of any kind approved for EGPA, GSK noted.