Janssen Biotech, Inc., a Janssen Pharmaceutical Company of Johnson & Johnson, announced that FDA has approved Darzalex (daratumumab) injection for intravenous infusion for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.

Dosage and Administration: The recommended dose of DARZALEX is 16 mg/kg body weight administered as an intravenous infusion. The dosing schedule begins with weekly administration (weeks 1-8) and reduces in frequency over time to every two weeks (weeks 9-24) and ultimately every four weeks (week 25 onwards until disease progression).

Adverse Events: The most frequently reported adverse reactions (incidence ≥20%) were: fatigue, nausea, back pain, pyrexia, cough and upper respiratory tract infection. In data from three pooled clinical studies including a total of 156 patients, four percent of patients discontinued treatment due to adverse reactions. Infusion reactions were reported in approximately half of all patients treated with Darzalex. Common (≥5 percent) symptoms of infusion reactions included nasal congestion, chills, cough, allergic rhinitis, throat irritation, dyspnea (shortness of breath) and nausea. Severe infusion reactions, including bronchospasm, dyspnea, hypoxia and hypertension (<2 percent each).

Citation: DARZALEX (daratumumab) approved by U.S. FDA: First human anti-CD38 monoclonal antibody available for the treatment of multiple myeloma. [news release]. Horsham, PA: Janssen Biotech; November 16, 2015. http://www.jnj.com/news/all/DARZALEX-daratumumab-Approved-by-US-FDA-First-Human-Anti-CD38-Monoclonal-Antibody-Available-for-the-Treatment-of-Multiple-Myeloma. Accessed November 19, 2015.