FDA Approves Zejula as First-line Maintenance Therapy for Advanced Ovarian Cancer

FDA Approves Zejula as First-line Maintenance Therapy for Advanced Ovarian Cancer
The U.S. Food and Drug Administration (FDA) has approved Zejula (niraparib) as a first-line maintenance therapy for women with advanced ovarian cancer who responded to platinum-based chemotherapy, regardless of their BRCA mutation status. This indication also includes patients with advanced fallopian tube or primary peritoneal cancer. The decision comes two months after FDA’s acceptance of a supplemental New Drug Application (sNDA), which was reviewed under the Real-Time Oncology Review (RTOR) pilot program, designed to speed the review process. According to the FDA, the application was approved two months before the agency’s goal date for a decision. Zejula is now approved in the U.S. in three treatment regimens for women with advanced ovarian cancer, regardless of BRCA mutations. The previous two are as a maintenance therapy for recurrent ovarian cancer that responded to platinum-based chemotherapy, and as a late-line therapy for tumors positive for homologous recombination deficiency (HRD). That is, tumors with mutations in certain genes involved in DNA repair, including BRCA genes, or with genomic instability — a high frequency of mutations within the genome. Because such tumors are more dependent on other DNA repair mechanisms involving the PARP enzyme — a DNA damage sensor — they are more likely to respond to treatments blocking PARP activity (PARP inhibitors), such as Zejula. Zejula is marketed by Tesaro, a subsidiary of GlaxoSmithKline (GSK), in the U.S. and in Europe. The therapy is also being reviewed for the same indication in China. “Women with advanced ovarian cancer have a five-year survival rate of less than 50%. This expanded indication means that many more women with this devastating disease can receive earl
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