Zejula FDA Approved for Advanced Ovarian Cancer with HRD-Positive Status

November 2019, Vol 9, No 11

On October 23, 2019, the FDA approved niraparib (Zejula; Tesaro), a poly (ADP-ribose) polymerase inhibitor, for the treatment of patients with advanced homologous recombination deficiency (HRD)-positive ovarian, fallopian tube, or primary peritoneal cancer who have received ≥3 previous lines of chemotherapy. The FDA used its priority review program for this approval.

This is an expanded indication for niraparib, which was originally approved by the FDA in March 2017 for the maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy.

This new indication is based on results of the phase 2 multicenter, open-label, single-arm QUADRA clinical trial of 98 patients with advanced ovarian cancer with HRD-­positive tumors. HRD status was determined by a companion diagnostic, Myriad Genetics’ myChoice CDx, which was also FDA approved on October 23, 2019. Treatment with niraparib elicited an overall response rate of 24% (all of which were partial responses) and an estimated median duration of response of 8.3 months.

Adverse reactions in the QUADRA trial led to dose reduction or interruption in 73% of patients receiving niraparib. The most common adverse reactions (>5%) resulting in dose reduction or interruption were thrombocytopenia (40%), anemia (21%), neutropenia (11%), nausea (13%), vomiting (11%), fatigue (9%), and abdominal pain (5%).

“Ovarian cancer has a high rate of recurrence, so there is a real need for therapies for women whose cancer has progressed through multiple lines of treatment and who have few or no options left,” said QUADRA’s lead investigator, Kathleen Moore, MD, Director, Oklahoma TSET Phase I Program, Associate Professor, Section of Gynecologic Oncology, Stephenson Cancer Center, University of Oklahoma. “It’s meaningful to see that Zejula has been approved as a late-line treatment for women including those with and without BRCA mutations.”

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