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FDA approves rucaparib for maintenance treatment of recurrent ovarian, fallopian tube, or primary peritoneal cancer

On April 6, 2018, the Food and Drug Administration approved rucaparib (Rubraca®, Clovis Oncology Inc.), a poly ADP-ribose polymerase (PARP) inhibitor, for the maintenance treatment of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

Rubraca (rucaparib) is an inhibitor of poly(ADP-ribose) polymerase (PARP) enzymes that block the repair of damaged DNA in cancer cells, and, as a result, causes the cancer cells to die.

The drug was first given conditional clearance in the US for the treatment of adult patients with deleterious BRCA mutation (germline and/or somatic) associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies, which has now also been converted into full approval.

Commenting on the approval, Patrick Mahaffy, chief executive and president of Clovis Oncology, said it “provides a meaningful advancement for the treatment of women with recurrent ovarian cancer, offering them the potential to reduce their risk of disease progression following platinum-based chemotherapy.

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