Empliciti Approved for the Treatment of Multiple Myeloma
November 30, 2015 – The U.S. Food and Drug Administration (FDA) approved Empliciti (elotuzumab) manufactured by Bristol-Myers Squibb jointly with AbbVie, for use in combination with Celgene’s Revlimid (lenalidomide) and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior therapies. Multiple myeloma is cancer of bone marrow cells. It affects approximately 27,000 individuals and has caused an approximate 11,000 deaths this past year in the U.S. Emplicity was approved several months ahead of schedule under FDA’s breakthrough therapy, orphan drug, and priority review programs. Empliciti is an immunostimulatory antibody that targets SLAMF7 glycoproteins that accumulate on the surfaces of multiple myeloma and other cells. It is the second monoclonal antibody approved by FDA to treat multiple myeloma. It causes cancer cells to break up while also promoting immune responses. Recommended dose for Empliciti is 10mg/kg administered intravenously weekly for the first two cycles and every two weeks thereafter until disease progression or unacceptable toxicity. Dosage forms include 300mg or 400mg lyophilized powder in a single dose vial for reconstitution and injection. The cost of Emplicity is expected to be approximately $140,000 for the first year, and approximately $120,000 annually thereafter. Marketing for Empliciti will be carried out by Bristol-Myers Squibb, and will be available through open distribution.
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. All trademarks are the property of their respective owners.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.