FDA Approves Zejula as Maintenance Therapy for Ovarian, Other Women’s Cancers

FDA Approves Zejula as Maintenance Therapy for Ovarian, Other Women’s Cancers
The United States has approved Tesaro’s Zejula (niraparib) as a maintenance therapy for adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. The Federal Drug Administration sign-off indicates that regulators believe Zejula's can delay cancer growth in patients who have shown a complete or partial response to platinum-based chemotherapy. “Maintenance therapy is an important part of a cancer treatment regimen for patients who have responded positively to a primary treatment,” the FDA's Richard Pazdur, MD, said in a press release. “Zejula offers patients a new treatment option that may help delay the future growth of these cancers, regardless of whether they have a specific genetic mutation.” Pazdur is acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. He is also director of the FDA’s Oncology Center of Excellence. The National Cancer Institute estimates that in 2017 more than 22,000 women will be diagnosed with epithelial ovarian, fallopian tube, or primary peritoneal cancer, and more than 14,000 patients will die of those cancers. Zejula, is an oral, once-a-day poly(ADP-ribose) polymerase (PARP) 1/2 inhibitor. It the only one of this class of drugs the FDA has approved as a maintenance therapy for women with recurrent ovarian, fallopian, or primary peritoneal cancers. Zejula’s effectiveness and safety were evaluated in a double-blind, placebo-controlled, international Pha
Subscribe or to access all post and page content.

Tagged , , , .

Daniela holds a PhD in Clinical Psychology from The University of Edinburgh, United Kingdom, a MSc in Health Psychology and a BSc in Clinical Psychology. Her work has been focused on vulnerability to psychopathology and early identification and intervention in psychosis.

Leave a Comment

Your email address will not be published. Required fields are marked *