(May 4, 2020) On April 29th, the Food and Drug Administration approved niraparib (Zejula, GlaxoSmithKline) as a first-line maintenance treatment for advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer, regardless of BRCA mutation status.
Niraparib was first approved by the FDA for treatment of recurrent ovarian cancer in 2017. This most recent approval means ovarian cancer patients do not need to have experienced a recurrence to receive the drug; advanced ovarian cancer patients can now receive niraparib as first-line maintenance treatment. Previously, only patients with BRCA mutations were eligible for treatment with a PARP inhibitor following completion of chemotherapy.
Per the FDA, “The trial demonstrated a statistically significant improvement in [progression-free survival] for patients randomized to niraparib compared with placebo in the homologous recombination deficient and overall population.”
Dr. Bradley Monk (University of Arizona College of Medicine, Phoenix Creighton University School of Medicine at St. Joseph’s Hospital Phoenix) an investigator involved in the double-blind/randomized Phase 3 that produced the data leading to this approval was quoted: “The positive data observed regardless of biomarker status in this study is extremely encouraging and suggests benefit beyond the BRCAm population.”
Said Dr. Monk, “This approval is an important step forward in the treatment of ovarian cancer. In my opinion, maintenance treatment with niraparib should be considered an option for appropriate patients who responded to first-line platinum-based chemotherapy versus active surveillance.”