Darzalex Granted New Indication to Treat Multiple Myeloma
June 27, 2019 – The U.S. FDA has approved a new indication for Darzalex® (daratumumab), manufactured by Janssen Pharmaceuticals. It is now approved for use in combination with Revlimid® (lenalidomide – Celgene) and dexamethasone (Rd) to treat patients with newly diagnosed multiple myeloma who are ineligible for an autologous stem cell transplant (ASCT).
Multiple myeloma affects plasma cells found in the bone marrow and can spread rapidly. The abnormal plasma cells produced by the disease crowd out healthy plasma cells, which are needed to create antibodies that fight infection. The cancerous plasma cells can reduce the body’s resistance to infection, and produce abnormal antibodies called monoclonal or M proteins that can damage the body. Tumor growth may also weaken the bones and increase risk of fracture.
In a clinical study, Darzalex in combination with Rd reduced the risk of disease progression or death by 44% percent compared to treatment with Rd alone. The combination also increased the rate of complete response (CR) or better (48% vs. 25%), very good partial response (VGPR) or better (79% vs. 53%), and overall response (93% vs. 81%). The rate of minimal residual disease (MRD) negativity was three times higher with Darzalex and Rd compared to Rd alone (24% vs. 7%). Patients who test MRD negative have less than one myeloma cell per one million bone marrow cells.
Recommended dosing under the new indication is 16mg/kg of body weight administered via intravenous (IV) infusion weekly for eight doses, then every two weeks for an additional eight doses. Each dose thereafter should be given once every four weeks until disease progression or unacceptable toxicity.
Darzalex originally received FDA approval in 2015, and now carries six indications for the treatment of multiple myeloma.