GSK’s Zejula and AZ’s Lynparza leap toward broader EU approval

GlaxoSmithKline’s Zejula and AstraZeneca’s Lynparza have both moved towards EU approval in new indications after receiving positive opinions from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).

Zejula (niraparib) won a positive opinion recommending it for approval as a first-line monotherapy maintenance treatment for women with advanced ovarian cancer who responded to platinum-based chemotherapy, regardless of biomarker status.

The application is based on data from GSK’s phase III PRIMA study, which demonstrated a clinically meaningful progression-free survival benefit of Zejula treatment in the first-line setting.

If the EMA decides to fully approve Zejula in this indication, it could become the first monotherapy PARP inhibitor to be backed as a first-line maintenance treatment following platinum response regardless of BRCA mutation status, according to GSK.

Lynparza, on the other hand, has been recommended for approval in the EU for patients with metastatic castration-resistant prostate cancer (mCRPC), with BRCA 1/2 mutations. The CHMP also backed the PARP inhibitor for use as a first-line maintenance treatment, in combination with bevacizumab, for HRD-positive advanced ovarian cancer.

The mCRPC recommendation is based on results from a subgroup analysis of patients with BRCA 1/2 mutations in the PROfound phase III trial.

In the phase III PAOLA trial, Lynparza in combination with bevacizumab maintenance treatment reduced the risk of disease progression or death by 67% in HRD-positive advanced ovarian cancer patients.

“Half of all newly diagnosed patients with advanced ovarian cancer have HRD-positive tumours. Lynparza together with bevacizumab has demonstrated a median progression-free survival benefit of more than three years, offering new hope for women in this setting,” said José Baselga, executive vice president, Oncology R&D at AZ.