EU approves Zejula as a first-line monotherapy maintenance treatment in advanced ovarian cancer
pharmafile | October 30, 2020 | News story | Medical Communications |
The European Commission has approved GlaxoSmithKline’s Zeljula as a first line monotherapy maintenance treatment for adult patients with ovarian cancer who are in complete or partial response after receiving platinum-based chemotherapy.
The approval makes the drug the only polymerase inhibitor approved in the European Union for use as a monotherapy for patients with advanced ovarian cancer, regardless of their biomarker status.
This follows the FDA granting a New Drug Application for Zeljula in April for the same indication. This was supported by data from the Phase 3 PRIMA study that showed the meaningful progression-free survival benefit of Zejula in the first-line maintenance setting. This was carried out on patients with newly diagnosed advanced ovarian cancer who responded to first-line treatment with platinum-based chemotherapy.
Dr Antonio Gonzalez-Martin, Co-Director, Department of Medical Oncology, Clinica Universidad de Navarra and Primary Investigator for PRIMA, said: “Until now, only women with BRC-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. Expanding the potential use of Zejula, regardless of biomarker status, is an important step forward in treating this challenging cancer.”
Zeljula’s safteu profile in the PRIMA study was consistent with the previously observed clinical safety profile.
“Having a new first-line maintenance option for patients with platinum-responsive advanced ovarian cancer in Europe — regardless of BRCA mutation status — speaks to the important role of PARP inhibitors in the fight against ovarian cancer,” explained Clara MacKay, Chief Executive Officer of the World Ovarian Cancer Coalition. “We are especially delighted that today’s approval means that more women in Europe who are diagnosed with ovarian cancer will have this new treatment option. We appreciate the commitment and scientific leadership required to develop innovative new therapies that address unmet needs in women’s cancer.”
In Europe, ovarian cancer is the sixth deadliest cancer among women, with more than 65,000 being diagnosed each year. 85% of patients will see the disease return at some point.
Conor Kavanagh
