The recent first global approval of niraparib has been reviewed in detail in the First Global Approval report in Adis journal Drugs, based on the development milestones tracked in AdisInsight.
In March 2017, niraparib (Zejula™), developed by Tesaro Inc., received its first global approval in the USA for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. It is also under regulatory review in the EU for use as maintenance treatment in patients with platinum-sensitive, recurrent epithelial ovarian cancer who are in response to platinum-based chemotherapy.
Niraparib is a once-daily, oral, small molecule inhibitor of poly(ADP-ribose) polymerase (PARP) enzymes, that is highly selective to PARP-1 and PARP-2. PARP is involved with cellular processes including programmed cell death and DNA repair, particularly of defects that are caused by aberrations in DNA repair genes BRCA1 and BRCA2; these mutations predispose individuals to hereditary ovarian and breast cancer.
According to the National Cancer Institute, more than 22,400 women are predicted to be diagnosed with ovarian-related cancers in 2017, resulting in more than 14,000 deaths.1
Niraparib was given Fast Track, Priority Review and Breakthrough Therapy designation by the US FDA as well as Orphan Drug designation specifically for treating recurrent epithelial ovarian cancer.2 It is the first PARP inhibitor to be approved by the FDA that does not need biomarker testing for BRCA mutations.3
“Maintenance therapy is an important part of a cancer treatment regimen for patients who have responded positively to a primary treatment,” said Richard Pazdur, M.D., acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research and director of the FDA’s Oncology Center of Excellence.4
Further, Audra Moran, President and CEO of Ovarian Cancer Research Fund Alliance commented that “Women with recurrent ovarian cancer often experience considerable fear and anxiety about future recurrences,” and that “Zejula may offer patients and their families a treatment option during this stressful period. The ovarian cancer community is eager for new treatment options, and we are glad that Zejula will be available to women that have completed their platinum-based chemotherapy.”5
Niraparib is also under clinical investigation (various phases) globally in patients with platinum-sensitive, relapsed ovarian, fallopian tube and peritoneal cancers, endometrial cancer, late-stage breast cancer, prostate cancer, Ewing’s sarcoma and other solid tumours.
The efficacy of niraparib is regardless of platinum sensitivity and independent of BRCA mutation or biomarker status.
Image credit: freshidea / Fotolia