全球第一个anti-CD38的抗癌单抗daratumumab，获FDA加速批准用于治疗多发性骨髓瘤的新药。 继2015年11月美国食品和药物管理局（FDA）加速批准了Daratumumab（商品名Darzalex, 美国詹森生物技术公司生产）单药治疗之前接受过至少三种治疗的多发性骨髓瘤后，2016年11月21日，美国食品和药物管理局（FDA）批准了Daratumumab（商品名Darzalex）和来那度胺（Lenalidomide, 商品名Revlimid）加地赛米松（Dexamethasone）或硼替佐米（Bortezomib，商品名万珂Velcade）加地赛米松（Dexamethasone）用于治疗之前接受过至少一种治疗的多发性骨髓瘤。Daratumumab（商品名Darzalex）是抗CD38的单克隆抗体。 此次批准是基于两项临床研究的有效结果。在第一项临床研究中，Daratumumab（商品名Darzalex）和来那度胺加地赛米松要明显优于来那度胺加地赛米松，Daratumumab（商品名Darzalex）和来那度胺加地赛米松治疗的中位无进展生存期尚未达到，而来那度胺加地赛米松治疗的中位无进展生存期为18.4个月，代表Daratumumab（商品名Darzalex）可降低疾病进展或死亡的风险高达63%。 在第二项临床研究中，Daratumumab（商品名Darzalex）和硼替佐米加地赛米松要明显优于硼替佐米加地赛米松，Daratumumab（商品名Darzalex）和硼替佐米加地赛米松治疗的中位无进展生存期尚未达到，而硼替佐米加地赛米松治疗的中位无进展生存期为7.2个月，代表Daratumumab（商品名Darzalex）可降低疾病进展或死亡的风险高达61%。 Daratumumab（商品名Darzalex）的推荐剂量为16毫克/公斤体重，静脉滴注。   Darzalex(Daratumumab Intravenous Injection) DARZALEX Rx Generic Name and Formulations: Daratumumab 100mg/5mL, 400mg/20mL; per vial; soln for IV infusion after dilution; contains mannitol; preservative-free. Company: Janssen Biotech, Inc. Select therapeutic use: Leukemias, lymphomas, and other hematologic cancers Indications for DARZALEX: Treatment of multiple myeloma: as combination therapy with lenalidomide and dexamethasone, or bortezomib and dexamethasone, in patients who have received ≥1 prior therapy; as combination therapy with pomalidomide and dexamethasone in patients who have received ≥2 prior therapies including lenalidomide and a proteasome inhibitor (PI); or as monotherapy in patients who have received ≥3 prior lines of therapy including a PI and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent. Adult: Pre-medicate with corticosteroids (long- or intermediate-acting), oral antipyretics, oral or IV antihistamines 1–3 hours prior to every infusion and administer oral corticosteroids post-infusion. Give only as IV infusion. Initially infuse at 50mL/hr for first two infusions, then 100mL/hr for subsequent infusions; may increase by 50mL/hr every hour; max 200mL/hr. Monotherapy and combination therapy with lenalidomide or pomalidomide and dexamethasone: 16mg/kg weekly at Weeks 1–8, every 2 weeks at Weeks 9–24, then every 4 weeks at Week 25 onwards until disease progression. Combination therapy with bortezomib and dexamethasone: 16mg/kg weekly at Weeks 1–9, every three weeks at Weeks 10–24, then every four weeks at Week 25 onwards until disease progression. Management of infusion reactions, pre- and post-infusion medications, others: see full labeling. Prophylaxis for herpes zoster reactivation: initiate antiviral prophylaxis within 1 week after starting therapy and continue for 3 months after treatment. Children: Not established. Warnings/Precautions: Should be administered by a healthcare professional with immediate access to emergency equipment and appropriate medical support. Monitor frequently for infusion reactions; interrupt treatment for infusion reactions of any severity. Permanently discontinue if life-threatening (Grade 4) or upon 3rd recurrence of Grade 3 infusion reactions occur; for Grade 1, 2, or 3 reactions, reduce the infusion rate when restarting. History of COPD: may require additional post-infusion drugs; consider prescribing short- or long-acting bronchodilators and inhaled corticosteroids. Interference with cross-matching and RBC antibody screening; type/screen patients prior to initiating treatment. Increased neutropenia (monitor for infections) and thrombocytopenia: obtain CBCs during therapy; dose delay may be required to allow recovery of neutrophils and platelets. Neonates/infants: defer live vaccines if exposed to drug in utero until hematology evaluation. Pregnancy. Females of reproductive potential should use effective contraception during treatment and for 3 months after cessation. Nursing mothers. Interactions: Interferes with Indirect Antiglobulin (Coombs) Test, serum protein electrophoresis and immunofixation assays leading to false (+) results. Pharmacological Class: CD38-directed monoclonal antibody. Adverse Reactions: Infusion reactions, neutropenia, thrombocytopenia, fatigue, nausea, diarrhea, constipation, vomiting, muscle spasms, arthralgia, back pain, pyrexia, chills, dizziness, insomnia, cough, dyspnea, peripheral edema, peripheral sensory neuropathy, upper respiratory tract infection. Generic Availability: NO How Supplied: Single-dose vial—1 若需完整的处方信息，请访问： http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761036s004lbl.pdf