New Indication for Darzalex
June 16, 2017 – The U.S. FDA has approved a new indication for Darzalex® (daratumumab), manufactured by Janssen Biotech. Darzalex is now approved for use, in combination with pomalidomide and dexamethasone, to treat patients with multiple myeloma who have received at least two prior therapies including Revlimid® (lenalidomide), manufactured by Celgene, and a proteasome inhibitor (PI).
Darzalex, an injectable CD38-directed antibody, was originally approved in November of 2015 for use as a monotherapy in patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent. In November of 2016, it received additional approvals for use in combination with dexamethasone and either lenalidomide or Takeda’s Velcade®, for treatment of patients with multiple myeloma who have received at least one prior therapy.
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.
- 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
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.