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GSK ovarian cancer drug Zejula wins expanded US FDA approval

The U.S. Food and Drug Administration granted expanded approval for GlaxoSmithKline PLC's Zejula to treat certain patients with advanced ovarian cancer.

The drug regulator has approved Zejula, or niraparib, to treat advanced ovarian, fallopian tube or primary peritoneal cancer patients who have been treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency.

In patients with homologous recombination deficiency, ovarian cancer cells have trouble repairing themselves. They exhibit specific clinical behaviors and improved responses to platinum-based chemotherapy and a class of drugs called PARP inhibitors, such as Zejula.

GlaxoSmithKline gained Zejula from its $5.1 billion acquisition of Waltham, Mass.-based cancer-drug maker Tesaro Inc.

Zejula was initially approved by the FDA in March 2017 for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy.

The expanded approval is based on results from a phase 2 study, named Quadra, where 29% of the patients who received Zejula saw their tumors shrink or become undetectable. The U.S. regulator granted priority review to GSK's application for expanded use of Zejula in June.

In addition, the regulator authorized the use of Myriad Genetics Inc.'s myChoice CDX for use as a companion diagnostic to identify women with advanced ovarian cancer who are candidates for Zejula in the late-line treatment setting.

Salt Lake City-based Myriad's myChoice CDx detects variations in the BRCA1 and BRCA2 genes to determine homologous recombination deficiency and identifies the presence of tumors.