ASH Clinical News ACN_5.2_digital | Page 44

A BTKi for adult patients with MCL after one prior therapy 1 CALQUENCE GO STRONG FOCUSED ON EFFICACY WITH DURABLE RESPONSES IN R/R MCL* † 80% ORR [95% CI: 72, 87] 1 ✦ 40% CR [95% CI: 31, 49] 1 ✦ Median DoR not reached at median follow-up of 15.2 months 1 *Independent Review Committee-assessed per 2014 Lugano Classifi cation response criteria for non-Hodgkin lymphoma. 1 INDICATION AND USAGE CALQUENCE is a Bruton tyrosine kinase (BTK) inhibitor indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verifi cation and description of clinical benefi t in confi rmatory trials. Consider the benefi t-risk of withholding CALQUENCE for 3 to 7 days pre- and post-surgery, depending upon the type of surgery and the risk of bleeding. Infection Serious infections (bacterial, viral, or fungal), including fatal events and opportunistic infections, have occurred in the combined safety database of 612 patients with hematologic malignancies treated with CALQUENCE monotherapy. Grade 3 or higher infections occurred in 18% of these patients. The most frequently reported Grade 3 or 4 infection was pneumonia. Infections due SELECT SAFETY INFORMATION to hepatitis B virus (HBV) reactivation and progressive Hemorrhage multifocal leukoencephalopathy (PML) have occurred. Serious hemorrhagic events, including fatal events, Monitor patients for signs and symptoms of infection have occurred in the combined safety database of 612 and treat as medically appropriate. Consider prophylaxis patients with hematologic malignancies treated with in patients who are at increased risk for opportunistic CALQUENCE monotherapy. Grade 3 or higher bleeding infections. events, including gastrointestinal, intracranial, and Cytopenias epistaxis, have been reported in 2% of patients. In the combined safety database of 612 patients with Overall, bleeding events, including bruising and hematologic malignancies, patients treated with petechiae of any grade, occurred in approximately CALQUENCE monotherapy experienced Grade 3 or 4 50% of patients with hematological malignancies. cytopenias, including neutropenia (23%), anemia The mechanism for the bleeding events is not (11%), and thrombocytopenia (8%), based on well understood. laboratory measurements. Monitor complete blood CALQUENCE may further increase the risk of counts monthly during treatment. hemorrhage in patients receiving antiplatelet or anticoagulant therapies, and patients should be monitored for signs of bleeding. Please see Brief Summary of complete Prescribing Information on adjacent pages. CALQUENCE is a registered trademark of the AstraZeneca group of companies ©2018 AstraZeneca. All rights reserved. US-23344 9/18 ADVERSE REACTIONS The most common adverse reactions (≥20%) of any grade were anemia,* thrombocytopenia,* headache (39%), neutropenia,* diarrhea (31%), fatigue (28%), myalgia (21%), and bruising (21%). *Treatment-emergent decreases (all grades) of hemoglobin (46%), platelets (44%), and neutrophils (36%) were based on laboratory measurements and adverse reactions. The most common Grade ≥ 3 non-hematological adverse reaction (reported in at least 2% of patients) was diarrhea (3.2%). Dosage reductions or discontinuations due to any adverse reaction were reported in 1.6% and 6.5% of patients, respectively. Increases in creatinine 1.5 to 3 times the upper limit of normal occurred in 4.8% of patients. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088. Investigator-assessed response rates were ORR: 81%; CR: 40%; PR: 41%. CR=complete response; DoR=duration of response; ORR=overall response rate (defi ned as the proportion of patients who achieved a CR or PR); PR=partial response; R/R=relapsed/refractory. Reference: 1. CALQUENCE [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2017. † VISIT CALQUENCE.COM/PHYSICIAN