For Immediate Release
Contact: Andrea Greif
Senior Director of Communications
(White Plains, NY) - February 26, 2015 - Two recent approvals by the U.S. Food and Drug Administration (FDA) will provide significant additional options for myeloma patients, both newly diagnosed and previously treated.
Myeloma is a relatively rare cancer of the plasma cells found primarily in the bone marrow. An estimated 95,874 people in the U.S. are living with, or in remission from, myeloma, and approximately 11,000 people in the U.S. die from the disease each year.
The FDA recently expanded the existing indication for Celgene's lenalidomide (marketed as Revlimid®) in combination with dexamethasone to include patients newly diagnosed with multiple myeloma. That means the drug, which was approved in 2006 for use in patients who had undergone at least one prior treatment, can now be used as a first-line therapy as well. LLS-funded investigators have participated in preclinical and clinical studies of this combination drug regimen.
In another development, Novartis Pharmaceuticals' panobinostat (marketed as Farydak®) was approved in combination with bortezomib and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior regimens, including bortezomib and an immunomodulatory agent. The drug was approved through the FDA priority review process which provides for an expedited review of drugs that are intended to treat a serious disease or condition and may provide a significant improvement over available therapy.
"Treatment options for myeloma patients have grown significantly over the past few years and this is a very hopeful time," said Louis J. DeGennaro, The Leukemia & Lymphoma Society's (LLS) president and CEO. "Unfortunately there's still not a cure but advances in care and treatment are leading to progress in disease management and better overall survival rates."
Lenalidomide's approval was based on clinical evidence demonstrating that starting and keeping newly diagnosed multiple myeloma patients on lenalidomide significantly improved treatment outcome. In the new data, a Phase III study evaluated continuous lenalidomide in combination with dexamethasone versus melphalan, prednisone and thalidomide (MPT) in 1,623 newly diagnosed patients who were not candidates for stem cell transplant.The median progression-free survival was 25.5 months in the lenalidomide-dexamethasone arm and 21.2 months in the MPT arm. The median overall survival was 58.9 months in the continous lenalidomide-dexamethasone arm and 48.5 months in the MPT arm.
Panobinostat's approval was based on a large clinical trial where panobinostat was administered orally in combination with previously approved agents (bortezomib and dexamethasone) compared to a control group (placebo-bortezomib-dexamethasone). Myeloma patients who received the panobinostat-containing regimen had a delay in their disease progression of 10.6 months compared to 5.8 months for those in the control group. Accelerated approval of panobinostat by the FDA requires the sponsor to conduct an additional trial to verify the benefit of the drug. Toxicities attributed to panobinostat have been noted, including a boxed warning alerting patients and health care providers of certain severe side-effects that may occur.
Celgene, which supports LLS's Quest for Cures grants program to fund priority research areas, also has an application under review with the European Medicines Agency (EMA) for approval to use lenalidomide for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.
About The Leukemia & Lymphoma Society
The Leukemia & Lymphoma Society ® (LLS) is the world's largest voluntary health agency dedicated to blood cancer. The LLS mission: Cure leukemia, lymphoma, Hodgkin's disease and myeloma, and improve the quality of life of patients and their families. LLS funds lifesaving blood cancer research around the world, provides free information and support services, and is the voice for all blood cancer patients seeking access to quality, affordable, coordinated care.
Founded in 1949 and headquartered in White Plains, NY, LLS has chapters throughout the United States and Canada. To learn more, visit www.LLS.org. Patients should contact the Information Resource Center at (800) 955-4572, Monday through Friday, 9 a.m. to 9 p.m. ET.