New Indication for Darzalex
May 8, 2018 – The U.S. FDA has approved a new indication for Darzalex® (daratumumab), manufactured by Janssen Pharmaceuticals and Genmab. It can now be used in combination with Takeda’s Velcade® (bortezomib), melphalan, and prednisone (VMP) as a first-line treatment for patients with multiple myeloma who are not eligible for autologous stem cell transplants (ASCTs). Darzalex is the first monoclonal antibody to receive FDA approval for use in newly diagnosed cancer patients.
Approval was based on clinical trials in which Darzalex with VMP cut the risk of disease progression or death by half for newly diagnosed patients after a period of 16.5 months, compared to use of VMP alone. A durable response to initial therapy may help patients with multiple myeloma live longer, higher quality lives, as the disease can be difficult to treat once it relapses.
According to the American Cancer Society, an estimated 30,770 Americans will be diagnosed with multiple myeloma in 2018. Roughly 12,770 Americans are anticipated to die of the disease in the same year. The cancer begins in plasma cells, which prevents the body from creating healthy white blood cells. It spreads first in bone marrow, and can progress to affect other organs in the body over time.
Darzalex, first approved in 2015, now holds five indications for treatment of multiple myeloma.
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.