ASH Clinical News Focus on Myeloma | Page 3

Ne w In dic at ion RESPOND with the power of significantly improved progression-free survival (PFS) Posterior Reversible Encephalopathy Syndrome (PRES): The KYPROLIS regimen significantly improved PFS in patients with relapsed multiple myeloma Cases of PRES have occurred in patients receiving Kyprolis. PRES was formerly known as Reversible Posterior Leukoencephalopathy Syndrome. Consider a neuro-radiological imaging (MRI) for onset of visual or neurological symptoms. Discontinue Kyprolis if PRES is 1 suspected and evaluate. The safety of reinitiating Kyprolis therapy in patients previously experiencing PRES is not known. In the ASPIRE study of KYPROLIS + lenalidomide + low-dose Embryo-fetal Toxicity: Kyprolis can cause fetal harm when dexamethasone (KRd) vs lenalidomide + low-dose dexamethasone delivered improved efficacy with a safety administered to a pregnant woman based on its mechanism of action (Rd), the KYPROLIS regimen profile comparable to Rd.1,2* and findings in animals. Females of reproductive potential should be advised to avoid becoming pregnant while being treated with Kyprolis and the potential hazard to the fetus if Kyprolis is used during pregnancy. 26.3 months median progression-free ADVERSE REACTIONS The most common adverse events occurring in at least 20% of patients treated with Kyprolis in the combination therapy trial: decreased lymphocytes, decreased absolute neutrophil count, decreased phosphorus, anemia, neutropenia, decreased total white blood cell count, decreased platelets, diarrhea, fatigue, thrombocytopenia, pyrexia, muscle spasm, cough, upper respiratory tract infection, decreased hemoglobin, hypokalemia. References: 1. KYPROLIS [prescribing information]. Thousand Oaks, CA: Onyx Pharmaceuticals, Inc., an Amgen Inc. subsidiary; 2015. 2. Stewart AK, Rajkumar SV, Dimopoulos MA, et al; for the ASPIRE Investigators. Carfilzomib, lenalidomide, and dexamethasone for relapsed multiple myeloma. N Engl J Med. 2015;372(2):142-152. Please see Brief Summary of full Prescribing Information on adjacent pages. survival with the KYPROLIS regimen vs 17.6 months with Rd, a 49% improvement over Rd (P value [two-sided] 0.0001)1 Find out more at www.kyprolis.com/hcp *ASPIRE was a global, multicenter, open-label, randomized phase 3 pivotal trial evaluating KYPROLIS in patients with relapsed multiple myeloma. 792 patients were randomized in a 1:1 ratio (396 patients to KRd, 396 to Rd). Patients received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity.1,2 The primary endpoint was progression-free survival. Secondary endpoints included overall survival, overall response rate (partial response or better), duration of response, and safety. 2