Kyprolis Combination Therapy Approved
January 21, 2016 – The U.S. Food and Drug Administration (FDA) approved Kyprolis (carfilzomib) for use in combination with dexamethasone or Revlimid (lenalidomide – Celgene) plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy. Full approval was also granted for the use of Kyprolis as a single agent to treat patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy. Kyprolis, manufactured by Amgen, is an infused proteasome inhibitor that was first approved in July 2012.
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 a 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.