HEMATOLOGY

Based on data from the phase II JULIET study, tisagenlecleucel has received FDA approval for the treatment of adult patients with relapsed/refractory large B-cell lymphoma—including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma—after 2 or more lines of systemic therapy.

The FDA approved several indications throughout the month of April 2018. A number of drugs were granted priority review and Fast Track designation. The FDA also halted all clinical trials using tazemetostat as treatment, and new initiatives were introduced to help ease the development of genetic and genomic-based tests. Check out our list of all FDA happenings from April 2018.

A herpes zoster subunit vaccine effectively prevented episodes of HZ and other related complications among patients who had recently underwent autologous hematopoietic stem cell transplant, according to the results of the phase III ZOE-HSCT trial presented at the 2018 BMT Tandem Meetings.

A recommendation has been made by the European Medicines Agency’s Committee for Medicinal Products for Human Use to add final overall survival data from the open-label phase III ASPIRE trial to the label for carfilzomib for the treatment of patients with relapsed/refractory multiple myeloma.

Experts are now questioning the previously established methods and strategies for the treatment of patients with multiple myeloma while new agents and treatment techniques continue to emerge in the field.

Zhijian “James” Chen, PhD, has proudly been recognized by the Foundation for the National Institutes of Health for his breakthrough discovery of the enzyme cyclic GMP-AMP synthase and its corresponding pathway. He will receive the 2018 Lurie Prize in Biomedical Sciences during the FNIH Award Ceremony to be held on May 16 in Washington, DC.

Treating Chronic Lymphocytic Leukemia in Elderly Patients

The National Cancer Institute-designated UC Davis Comprehensive Cancer Center has chosen Primo Nery Lara, Jr., MD, to serve as director. His position will include leading a team of over 300 scientists in their annual research, with an estimated annual research funding of $90 million. The clinical enterprise also serves over 10,000 regional patients annually.

Based on data from the ongoing phase III ADMIRAL study, Astellas Pharma, the manufacturer of&nbsp;gilteritinib, has announced the submission of a new drug application to the FDA seeking approval for the FLT3 inhibitor as a treatment for adult patients with <em>FLT3</em> mutation&ndash;positive relapsed or refractory acute myeloid leukemia.