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DECEMBER 18, 2016

Rubraca and Companion Diagnostic Approved for Advanced Ovarian Cancer

Drug: Rucaparib (Rubraca, Clovis)

Status: Approved for women with advanced ovarian cancer who have been treated with 2 or more chemotherapies and whose tumors have a specific genetic mutation (deleterious BRCA) as identified by an FDA-approved companion diagnostic test

Significant Data:

  • First and only poly(ADP-ribose) polymerase inhibitor approved for this indication in the US
  • Approval was based on 2, single-arm clinical trials involving 106 participants with BRCA-mutated advanced ovarian cancer