Rubraca Approved for Ovarian Cancer
December 19, 2016 - The U.S. FDA granted accelerated approval for Rubraca™ (rucaparib), manufactured by Clovis Oncology, Inc. Rubraca is indicated for ovarian cancer that has progressed despite at least two chemotherapy treatments and that has a deleterious BRAC genetic mutation as confirmed by an FDA-approved diagnostic test. Rubraca was granted accelerated approval which is something that is given to drugs where the clinical study information shows promise for treating serious or life-threatening diseases, even though studies are not completed. Rubraca is an oral drug with recommended dosing of 600mg twice a day until the cancer worsens or the patient cannot take the drug any longer. Clovis Oncology plans on launching Rubraca as soon as possible.
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 regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular 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
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.