Posted by Michael Wonder on 07 Apr 2018
Rubraca (rucaparib) approved in the U.S. as maintenance treatment of recurrent ovarian cancer
6 April 2018 - Rubraca is now indicated as maintenance treatment for women with recurrent ovarian cancer who are in a complete or partial response to platinum-based chemotherapy, regardless of BRCA mutation status – no biomarker testing required.
Clovis Oncology today announced that the U.S. FDA has approved Rubraca (rucaparib) tablets for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.
FDA granted regular approval for Rubraca in this second, broader and earlier-line indication on a priority review timeline based on positive data from the phase 3 ARIEL3 clinical trial. Biomarker testing is not required for patients to be prescribed Rubraca in this maintenance treatment indication.
