The FDA has granted a priority review designation to a supplemental biologics license application for Zejula for the treatment of certain patients with advanced ovarian, fallopian tube or primary peritoneal cancer.
The Food and Drug Administration (FDA) has granted a priority review designation to a supplemental biologics license application for Zejula (niraparib) for the treatment of certain patients with advanced ovarian, fallopian tube or primary peritoneal cancer.
Zejula is an oral, once-daily PARP inhibitor, that was approved by the FDA in March 2017 for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy.
The expanded indication would include patients who have been treated with three or more prior chemotherapy regimens, who have either a BRCA mutation or have homologous recombination deficiency (HRD) and progressed more than six months after their last platinum-based chemotherapy.
The designation is based on findings from the QUADRA study, which showed an overall response rate of 28% in patients who had HRD and received at least three prior lines of therapy. The FDA must decide on the application by October 24, 2019, according to a press release from GlaxoSmithKline, which has acquired Tesaro, the developer of Zejula.
“The results of the QUADRA study demonstrate that Zejula is active as a late-line treatment for patients beyond those with BRCA mutations,” Mary Lynne Hedley, president and chief operating officer of Tesaro, said in a press release. “With this study, we continue to advance our mission to provide more patients with ovarian cancer an opportunity to benefit from treatment with Zejula.”
In the study, 463 adult patients received Zejula at 300 mg daily until disease progression. At the time of data cut-off in April 2018, 21 patients remained on therapy. Patients had received an average of four prior lines of therapy and the median follow-up for overall survival was 12.2 months. Thirty-three percent of patients were resistant and 35% were refractory to the last administered platinum therapy.
The most common grade 3 or higher treatment-emergent side effects were anemia (24%) and thrombocytopenia (21%). The most common serious side effects were small intestinal obstruction (7%), thrombocytopenia (7%) and vomiting (6%). There was one death caused by gastric hemorrhage that was considered to be treatment-related.
“We know Zejula plays an important role in helping women with ovarian cancer whose disease has progressed despite initial therapy,” Dr. Hal Barron, chief scientific officer and president, R&D, GlaxoSmithKline, said in the press release. “Our hope is that over time, our ongoing clinical trials will demonstrate that this medicine can benefit even more patients.”
This article was adapted from a post that originally appeared on OncLive as, “FDA Grants Priority Review to Niraparib for Late-Stage Ovarian Cancer.”