New Indication for Rubraca
April 6, 2018 – The U.S. FDA has approved a new indication for Rubraca® (rucaparib), manufactured by Clovis Oncology, as a maintenance therapy for recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer in patients who have received platinum-based chemotherapy and are in a complete or partial response.
Approval for the new indication is based on a clinical study in which patients taking Rubraca had a median progression free survival rate of 10.8 months versus just 5.4 months in patients on placebo. Progression-free survival was even higher in patients with deleterious germline or somatic BRCA mutation at 16.6 months versus 5.4 months in the placebo group.
A PARP inhibitor, Rubraca works by blocking cancer cells’ ability to repair their DNA once it has been damaged. Recommended dosing is 600mg taken twice daily until disease progression or the patient can no longer tolerate treatment.
Rubraca is also indicated to treat 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. It was first approved in 2016.
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- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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