August 3, 2017 (Rye Brook, NY) - The Leukemia & Lymphoma Society (LLS) applauds the U.S. Food and Drug Administration (FDA) approval today of CPX-351 (VyxeosTM), an innovative combination of two chemotherapy drugs being used to treat two high-risk subgroups of acute myeloid leukemia (AML) patients. After more than four decades of little progress in treating AML, this approval marks the third drug approval for AML patients in just the past three months. LLS contributed sustained and significant support to advance this therapy.
LLS has funded the development of Vyxeos since 2009 through its Therapy Acceleration Program® (TAP). Under the TAP initiative, LLS partners directly with biotechnology companies to accelerate the development of promising therapies for unmet medical needs, many of which otherwise might not receive support. LLS partnered with Celator Pharmaceuticals, the developer of Vyxeos, through TAP; Celator was acquired by Jazz Pharmaceuticals last year.
The FDA approved Vyxeos to treat newly diagnosed adult AML patients who acquire AML after being treated for a previous cancer, a complication that occurs in approximately 8-10 percent of patients treated for cancer. Vyxeos also is approved for patients whose AML developed after progressing from a diagnosis of myelodysplastic syndrome, another form of blood cancer.
“The vision for our innovative Therapy Acceleration Program® has become a reality with this approval, which will help patients with high-risk AML who are in desperate need of more options,” said Louis J. DeGennaro, LLS president and CEO. “From the start, LLS recognized the potential of Vyxeos, and we are very gratified by this opportunity to deliver better treatments and outcomes for patients with high-risk AML. In its 10th year, TAP is demonstrating its effectiveness at accelerating cancer treatments, as Vyxeos is the first TAP-supported therapy approved by the FDA, a significant achievement for LLS’s venture philanthropy model. More LLS-supported therapies are currently under FDA review.”
AML is one of the most deadly blood cancers. There are 21,000 people diagnosed each year in the United States and 10,000 deaths. The standard treatment for AML has changed very little in more than 40 years. Vyxeos takes the two standard chemotherapy drugs and combines them in a single infusion to deliver a more optimal ratio of the drugs with less toxicity.
The approval of Vyxeos was based on an LLS-funded Phase 3 Clinical Trial in which the treatment significantly outperformed the standard therapy for patients with secondary acute myeloid leukemia (AML), a high-risk form of the blood cancer that progresses from other cancers, such as myelodysplastic syndromes or treatment for other cancers. The current prognosis for patients with this type of AML is exceptionally poor. Vyxeos enhanced median overall survival from 5.95 months to 9.56 months in the trial.
The investment in Vyxeos is part of LLS’s larger offensive against AML. As the world’s largest voluntary agency dedicated to blood cancers, LLS has taken the lead in efforts to change the paradigm of treatment for patients with AML, which remains one of the most lethal blood cancers. More than 25 percent of LLS’s research budget is dedicated to AML. With the launch of its Beat AML® Master Trial in 2016, LLS has convened an unprecedented collaboration of researchers at multiple cancer institutions, pharmaceutical and biotechnology companies, the FDA and patients, to use genomic information to identify patients’ AML subtypes and apply a precision medicine approach to treatment.
Two other TAP partners are in line for FDA review this year. LLS has partnered with Kite Pharma in the development of an immunotherapy. Kite’s therapy, KTE-C19 (Axi-cel), a CAR T-cell immunotherapy is under review by the FDA to treat patients with relapsed/refractory non-Hodgkin lymphoma and a decision is anticipated before the end of November. Stemline, another TAP partner, has a therapy in the pipeline for patients with a rare blood cancer called blastic plasmacytoid dendritic cell neoplasm (BPDCN) that has also shown strong promise and is on track for filing with the FDA.
Another LLS-supported CAR-T immunotherapy that was advanced through LLS’s traditional grants program is CTL-019 (tisagenlecleucel-T), which received a recommendation for approval from an FDA panel in July to treat relapsed and refractory acute lymphoblastic leukemia patients.
Click here to learn more about Vyxeos.
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 Rye Brook, 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.
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