American Society of Hematology

The Food and Drug Administration granted accelerated approval to polatuzumab vedotin-piiq (POLIVY, Genentech, Inc.), a CD79b-directed antibody-drug conjugate indicated in combination with bendamustine and a rituximab product for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, after at least two prior therapies.

The Food and Drug Administration approved the addition of overall survival data in labeling for gilteritinib (XOSPATA, Astellas Pharma US, Inc.), indicated for adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.

The Food and Drug Administration approved lenalidomide (REVLIMID®, Celgene Corp.) in combination with a rituximab product for previously treated follicular lymphoma (FL) and previously treated marginal zone lymphoma (MZL).

The Food and Drug Administration approved dalteparin sodium (FRAGMIN, Pfizer, Inc.) to reduce the recurrence of symptomatic venous thromboembolism (VTE) in pediatric patients 1 month of age and older.

ASH continues to advocate for adequate coverage and reimbursement for chimeric antigen receptor T-cell (CAR-T) therapy. In early August, the Centers for Medicare and Medicaid Services (CMS) finalized policies impacting both reimbursement of and coverage for CAR-T therapy. The final Inpatient Prospective Payment System (IPPS) rule, published on August 2, and the final Decision Memo for CAR T-cell Therapy for Cancers, issued August 7.

ASH continues to increase its efforts to expand and enhance the Society’s reach. NIH funding, efforts to ensure patient access to drugs, and sickle cell disease were top priorities on ASH’s advocacy agenda in 2018.

ASH continues to invest in and explore the important actions needed to make a significant difference in sickle cell disease (SCD) access to care, research, and global issues. Learn about the major advocacy-related initiatives undertaken by ASH in 2018.

In 2018, ASH worked to ensure patient access to care through a number of methods including ensuring drug access, pain management-related issues, and the Affordable Care Act.