FDA's Approval of Zejula Offers Patients with High-Grade Ovarian Cancer a Maintenance Therapy Option


The Food and Drug Administration’s recent approval of Zejula is different from previous approvals as it is indicated for all patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer, according to a gynecologic oncology expert.

The Food and Drug Administration’s (FDA) approval of Zejula (niraparib) for the frontline maintenance treatment of adults with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy is exciting news for patients, according to Dr. Erin E. Medlin.

“What is interesting about this approval is that it is different from the previous approval of Lynparza (olaparib) in the upfront setting, as it is approved for all patients with high-grade ovarian cancer with advanced stage cancer who have responded to a platinum-based therapy,” Medlin, a gynecologic oncologist at Penn Medicine Lancaster General Health, said in an interview with CURE®. “The other treatment has required patients to have certain mutations, but niraparib achieved approval for all patients regardless of their tumor biology.”

The approval was based on results from the double-blind, placebo-controlled PRIMA trial in which 733 patients, who were either in a complete or partial response from first-line chemotherapy, received either Zejula or placebo.

Progression-free survival (PFS) within the overall study population compared to the homologous recombination deficient population served as the main outcome of the study. Patients with ovarian cancer who have a homologous recombination deficiency often have improved responses to treatments that include PARP inhibitors like Zejula.

In both groups of patients, the researchers found a statistically significant improvement of PFS for patients who received Zejula compared to placebo. Patients with a homologous recombination deficiency had a PFS of 21.9 months compared to 10.4 months on placebo. In the overall population, PFS in patients who received Zejula was 13.8 months compared to 8.2 months in those who received placebo.

Medlin noted that patients should discuss with their providers how much of a benefit they may achieve with Zejula to determine if it is worth receiving the medication.

“Patients with certain tumor biology will benefit much greater than other patients, and there may be things such as side effects or costs that could play into the decision to go on this medication or not,” she said. “I think for certain patients, this will be the standard-of-care. For patients with a BRCA mutation, or homologous recombination deficiency, this absolutely will be the standard of care.”

Patients with high-grade ovarian cancer should discuss maintenance therapy options with their physician, as well as discuss testing their tumor to determine what kind of therapeutic benefit they would receive, according to Medlin. One thing that will surely change as a result of this approval, Medlin said, is that all patients will be offered this treatment option.

“When you talk about benefit, we talk in terms of time,” she said. “Patients with a homologous recombination deficiency will have a much greater benefit than those without that. Although all patients will benefit or can benefit (from this therapy), it is worth the discussion for all patients whether they want to go on this medication or not.”

Read CURE®’s original coverage on the approval of Zejula.

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