ASH News Daily 2012 - Saturday, December 8, 2012 - (Page C-11)

Saturday, December 8, 2012 ASH NewS DAily Page C–11 ® The Continuing Evolution of ASH: Turning Dreams into Reality Editor’s Note: This President’s Column, written by current president, Dr. Armand Keating, was previously published in the November/December 2012 issue of The Hematologist. grams and achieving goals that we only dreamed about when I first joined the Executive Committee in 2001. Who could have imagined that one day we would bring Highlights of ASH® to Latin America and Asia and reach hematologists from more than 30 countries – many of whom would not otherwise have been exposed to the research and clinical education presented at our annual meeting? Through ASH’s global outreach, we now deliver educational materials to institutions in developing countries, provide scholarships to physicians and laboratory scientists around the world, and facilitate an international consortium designed to improve clinical care and create the infrastructure to undertake network-based collaborations in acute leukemia. Within the Unites States, ASH has become an increasingly influential player in the area of advocacy and has a prominent role in affecting issues ranging from biomedical research funding to physician reimbursement to health-care delivery. This past year, ASH led the charge on drug shortage concerns by bringing the issue to the attention of Congress, H aving served as part of the ASH leadership team for 12 years, I am in a unique position to reflect on the enormous strides we have made as a society. Perhaps what strikes me the most is that we are now launching pro- Read Dr. Keating’s other President’s Columns from this past year and those from past presidents at www.hematology.org/ publications/ hematologist. 7 DRUG INTERACTIONS No formal drug-drug interaction studies have been conducted with ARZERRA. 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category C: There are no adequate or well-controlled studies of ofatumumab in pregnant women. A reproductive study in pregnant cynomolgus monkeys that received ofatumumab at doses up to 3.5 times the recommended human dose of ofatumumab did not demonstrate maternal toxicity or teratogenicity. Ofatumumab crossed the placental barrier, and fetuses exhibited depletion of peripheral B cells and decreased spleen and placental weights. ARZERRA should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. There are no human or animal data on the potential short- and long-term effects of perinatal B-cell depletion in offspring following in utero exposure to ofatumumab. Ofatumumab does not bind normal human tissues other than B lymphocytes. It is not known if binding occurs to unique embryonic or fetal tissue targets. In addition, the kinetics of B-lymphocyte recovery are unknown in offspring with B-cell depletion [see Nonclinical Toxicology (13.3)]. 8.3 Nursing Mothers It is not known whether ofatumumab is secreted in human milk; however, human IgG is secreted in human milk. Published data suggest that neonatal and infant consumption of breast milk does not result in substantial absorption of these maternal antibodies into circulation. Because the effects of local gastrointestinal and limited systemic exposure to ofatumumab are unknown, caution should be exercised when ARZERRA is administered to a nursing woman. 8.4 Pediatric Use Safety and effectiveness of ARZERRA have not been established in children. 8.5 Geriatric Use Clinical studies of ARZERRA did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects [see Clinical Pharmacology (12.3) of full prescribing information]. 8.6 Renal Impairment No formal studies of ARZERRA in patients with renal impairment have been conducted [see Clinical Pharmacology (12.3) of full prescribing information]. 8.7 Hepatic Impairment No formal studies of ARZERRA in patients with hepatic impairment have been conducted. 10 OVERDOSAGE No data are available regarding overdosage with ARZERRA. 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility No carcinogenicity or mutagenicity studies of ofatumumab have been conducted. In a repeat-dose toxicity study, no tumorigenic or unexpected mitogenic responses were noted in cynomolgus monkeys treated for 7 months with up to 3.5 times the human dose of ofatumumab. Effects on male and female fertility have not been evaluated in animal studies. 13.3 Reproductive and Developmental Toxicology Pregnant cynomolgus monkeys dosed with 0.7 or 3.5 times the human dose of ofatumumab weekly during the period of organogenesis (gestation days 20 to 50) had no maternal toxicity or teratogenicity. Both dose levels of ofatumumab depleted circulating B cells in the dams, with signs of initial B cell recovery 50 days after the final dose. Following Caesarean section at gestational day 100, fetuses from ofatumumab-treated dams exhibited decreases in mean peripheral B-cell counts (decreased to approximately 10% of control values), splenic B-cell counts (decreased to approximately 15 to 20% of control values), and spleen weights (decreased by 15% for the low-dose and by 30% for the high-dose group, compared to control values). Fetuses from treated dams exhibiting anti-ofatumumab antibody responses had higher B cell counts and higher spleen weights compared to the fetuses from other treated dams, indicating partial recovery in those animals developing anti-ofatumumab antibodies. When compared to control animals, fetuses from treated dams in both dose groups had a 10% decrease in mean placental weights. A 15% decrease in mean thymus weight compared to the controls was also observed in fetuses from dams treated with 3.5 times the human dose of ofatumumab. The biological significance of decreased placental and thymic weights is unknown. The kinetics of B-lymphocyte recovery and the potential long-term effects of perinatal B-cell depletion in offspring from ofatumumab-treated dams have not been studied in animals. 17 PATIENT COUNSELING INFORMATION Advise patients to contact a healthcare professional for any of the following: • igns and symptoms of infusion reactions including fever, chills, rash, S or breathing problems within 24 hours of infusion [see Warnings and Precautions (5.1) and Adverse Reactions (6.1)] • leeding, easy bruising, petechiae, pallor, worsening weakness, or fatigue B [see Warnings and Precautions (5.2)] • igns of infections including fever and cough [see Warnings and S Precautions (5.2) and Adverse Reactions (6.1)] • ew neurological symptoms such as confusion, dizziness or loss of N balance, difficulty talking or walking, or vision problems [see Warnings and Precautions (5.3)] • ymptoms of hepatitis including worsening fatigue or yellow discoloration S of skin or eyes [see Warnings and Precautions (5.4)] • ew or worsening abdominal pain or nausea [see Warnings and N Precautions (5.5)] • regnancy or nursing [see Use in Specific Populations (8.1, 8.3)] P Advise patients of the need for: • eriodic monitoring for blood counts [see Warnings and Precautions (5.2)] P • voiding vaccination with live viral vaccines [see Warnings and A Precautions (5.6)] Manufactured by: GLAXO GROUP LIMITED Greenford, Middlesex, UB6 0NN, United Kingdom U.S. Lic. 1809 Distributed by: GlaxoSmithKline Research Triangle Park, NC 27709 ©2011, GlaxoSmithKline. All rights reserved. September 2011 ARZ:6BRS ©2011 The GlaxoSmithKline Group of Companies All rights reserved. Printed in USA. AZA295R0 September 2011 identifying proposed solutions, and strengthening the final legislation to the benefit of hematologists and their patients. We have also taken an aggressive stance in the area of training future generations of hematologists by funding more than $4 million dollars annually in scholarships and research grants. For example, the Clinical Research Training Institute (CRTI), now in its 10th year, provides promising researchers exceptional training on how to conduct rigorous patient-oriented clinical research. Along the same lines, but with a different focus, the Translational Research Training in Hematology (TRTH) program, a joint effort with the European Hematology Association (EHA), draws on the strengths of this partnership to help position young scientists as global leaders in translational research. Additionally, we have two successful scholarship programs designed to increase the number of underrepresented minority scholars in the field. Perhaps ASH’s boldest initiative has been the bridge grant program, which will provide at least 30 one-year awards annually for the next three years, in the amount of $100,000 each, to ASH members who applied for an NIH R01 grant or equivalent but were denied funding due to budget cutbacks. The long-term goal of the award is to help sustain recipients’ research and contribute to their retention in hematology investigation. This program, the first targeted to the present crisis of NIH funding, commits a total of $9 million to this effort and catapults ASH once again into a leadership role within the biomedical research community. We are able to launch these programs because of the dedication of members and the involvement of committed leaders who have dared us to tackle new challenges, pursue creative initiatives, and dream big dreams. B:15.125” T:14” S:12”  http://www.hematology.org/publications/hematologist http://www.hematology.org/publications/hematologist http://www.hematology.org/publications/hematologist

Table of Contents for the Digital Edition of ASH News Daily 2012 - Saturday, December 8, 2012

ASH News Daily 2012 - Saturday, December 8, 2012

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