New York, NY (October 31, 2017) –The U.S. Food and Drug Administration (FDA) announced it has approved the use of obinutuzumab (Gazyva®) to treat patients with previously untreated advanced follicular lymphoma (FL).
Under the new indication, patients with stage II bulky, III or IV FL will be eligible to receive the drug in combination with chemotherapy, followed by obinutuzumab (Gazyva®) alone in those who responded, as a frontline therapy for the first time.
Follicular lymphoma is the most common indolent subtype of non-Hodgkin lymphoma (NHL), and often becomes more difficult to treat with each relapse. This marks the third blood cancer indication for obinutuzumab (Gazyva®), which was previously granted Priority Review status by the FDA.
“Today’s approval of obinutuzumab (Gazyva®) provides the first major advancement to the standard of frontline care for follicular lymphoma patients in over a decade,” said Meghan Gutierrez, Chief Executive Officer of the Lymphoma Research Foundation. “We commend the researchers and patients who participated in the trials to advance research and provide a new treatment option to follicular lymphoma patients and their loved ones.”
For more information on the FDA approval of obinutuzumab (Gazyva®), visit https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125486s017s018lbl.pdf.
For additional information on follicular lymphoma, visit www.focusonfl.org.
About the Lymphoma Research Foundation
The Lymphoma Research Foundation (LRF) is the nation’s largest non-profit organization devoted to funding innovative research and serving the lymphoma community through a comprehensive series of education programs, outreach initiatives and patient services. To date, LRF has awarded nearly $60 million in lymphoma-specific research.
For additional information on LRF’s research, education and services, visit lymphoma.org.
Since January of 2005, the Lymphoma Research Foundation has been proud to convene the Mantle Cell Lymphoma Consortium (MCLC), which is comprised of more than 100 laboratory and clinical scientists from North America and Europe who focus their research on MCL. The MCLC is designed to accelerate the understanding and treatment of MCL by bringing together these lead investigators, funding innovative studies and creating resources. LRF’s Mantle Cell Lymphoma Consortium is one of the Foundation’s longest running scientific program, encouraging collaboration and the sharing of research developments between the world’s leading MCL researchers, including LRF MCL Consortium members, MCL grantees, and scientists from the United States, Canada, and Europe. Since its inception, the MCL Scientific Workshop has helped researchers make significant strides in understanding MCL biology, evaluating potential new therapies, and optimizing the use of currently available therapies. Next year’s MCL Scientific Workshop will be held from April 25-26, 2018 in Atlanta, Georgia. For more information on the MCL Consortium and Scientific Workshop, visit www.lymphoma.org/MCLWorkshop.