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APRIL 6, 2018

FDA Grants New Indication for Rubraca

The FDA granted a new indication for rucaparib (Rubraca, Clovis Oncology) for the maintenance treatment of recurrent ovarian, fallopian tube or primary peritoneal cancers.

The agency also approved the complementary diagnostic test, FoundationFocus CDx BRCA LOH, for tumor samples to determine homologous recombination deficiency (HRD) status.

The FDA approved rucaparib, a poly ADP-ribose polymerase (PARP) inhibitor, for the maintenance treatment of recurrent epithelial ovarian, fallopian tube, or