ASH Clinical News May 2016

CLINICAL NEWS and fibrinolytic cascades. Paul G. Richardson, MD, from the Dana-Farber Cancer Institute, assessed rates of survival and complete response (CR) with defibrotide in patients with hepatic VOD/SOS with multi-organ failure in a multi-center, open-label, phase III study in which outcomes of patients receiving the intervention were compared with historical controls. “Although HCT practice has changed greatly over the past decades, hepatic VOD/SOS with multi-organ failure remains a very real and life-threatening complication post-HCT, for which there are no approved therapies,” Dr. Richardson and colleagues wrote. “In this context, defibrotide provides a promising treatment option for patients with a high unmet medical need.” The study was conducted at 35 centers in the United States, Canada, and Israel, and included pediatric and adult patients who were split into two cohorts: • Those treated with intravenous defibrotide 25 mg/kg/day in 4 divided doses, each infused over 2 hours every 6 hours for a minimum of 21 days (enrolled prospectively from July 2006 through June 2008; n=102) • Historical controls who were selected APPROVED The ﬁrst and only proteasome inhibitor indicated in combination with lenalidomide and dexamethasone for patients with multiple myeloma who have received at least 1 prior therapy. Visit NINLARO-hcp.com to learn more ADVERSE REACTIONS The most common adverse reactions (≥ 20%) in the NINLARO regimen and greater than the placebo regimen, respectively, were diarrhea (42%, 36%), constipation (34%, 25%), thrombocytopenia (78%, 54%; pooled from adverse events and laboratory data), peripheral neuropathy (28%, 21%), nausea (26%, 21%), peripheral edema (25%, 18%), vomiting (22%, 11%), and back pain (21%, 16%). Serious adverse reactions reported in ≥ 2% of patients included thrombocytopenia (2%) and diarrhea (2%). SPECIAL POPULATIONS • Hepatic Impairment: Reduce the NINLARO starting dose to 3 mg in patients with moderate or severe hepatic impairment. • Renal Impairment: Reduce the NINLARO starting dose to 3 mg in patients with severe renal impairment or end-stage renal disease requiring dialysis. NINLARO is not dialyzable. • Lactation: Advise women to discontinue nursing while on NINLARO. DRUG INTERACTIONS: Avoid concomitant administration of NINLARO with strong CYP3A inducers. Please see Brief Summary adjacent to this advertisement and NINLARO full Prescribing Information available at NINLARO-hcp.com. Takeda Oncology and are registered trademarks of Takeda Pharmaceutical Company Limited. NINLARO is a registered trademark of Millennium Pharmaceuticals, Inc. Copyright © 2016, Millennium Pharmaceuticals, Inc. All rights reserved. Printed in USA 3/16 USO/IXA/15/0135(2) retrospectively by an independent medical review committee from January 1995 through November 2007 (n=32) This study’s historical control selection methodology is “unique for such an uncommon and frequently fatal HCT complication,” the authors commented. “While randomized controlled trials represent the gold standard, the

ASH Clinical News May 2016 | Page 37