Posted from: Wednesday, May 16, 2018 - 04:22 PM - Present

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.

Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.

Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval.  Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval.  Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

*This is provided for information only.  The reference to any medication above does not mean the medication is covered by your plan.

 

Last Updated Friday, September 21, 2018 - 10:20 PM.