Celator Pharmaceuticals
Former TAP Partner
Celator Pharmaceuticals
Former TAP Partner
In 2009, LLS TAP invested $4.1 million in a phase 2 trial of CPX-351. After promising results, LLS TAP invested another $5 million into a phase 3 trial. The FDA granted Breakthrough Therapy designation in 2016, and CPX-351 was approved a year later for a number of blood cancers—including the first FDA approvals for two types of adult AML. After Celator’s acquisition by Jazz Pharmaceuticals LLS saw a return of $25.3 million.
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Vyxeos® (CPX-351), an innovative reformulation of two chemotherapies, was approved by the U.S. Food and Drug Administration on August 3 2017 and is the first approved treatment for adult patients with certain types of high-risk acute myeloid leukemia (AML): newly diagnosed therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC). On March 30 2021, the FDA revised the approval label to include pediatric patients aged 1 year and older.
Clinical data that supported the first approval application was published in J Clin Oncol.
Recent News
FDA Approves Vyxeos for Secondary Acute Myeloid Leukemia in Children
DUBLIN, March 30, 2021 - Jazz Pharmaceuticals plc (Nasdaq: JAZZ) announced that the U.S. Food and Drug Administration (FDA) approved a revised label for Vyxeos® (daunorubicin and cytarabine) to include a new indication to treat newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in pediatric patients aged one year and older.
Publication of CPX-351 Clinical Data in 'Blood Advances': Phase 3 Post-Hoc Analyses
March 16, 2021 - CPX-351 (Vyxeos, daunorubicin and cytarabine liposome for injection) is a dual-drug liposomal encapsulation of daunorubicin and cytarabine approved by the US Food and Drug Administration in 2017 and the European Medicines Agency in 2018 for the treatment of adults with newly diagnosed t-AML or AML with myelodysplasia-related changes (AML-MRC). In the primary analysis of data from the pivotal randomized phase 3 study in older adults with newly diagnosed high-risk/sAML, induction followed by consolidation with CPX-351 demonstrated a significantly improved median overall survival. After 5 years of follow-up, survival benefit was maintained.
LLS Applauds Data from Celator Study of CPX-351 for High-Risk AML Patients
White Plains, N.Y. (June 24, 2015) – Interim data released today by Celator Pharmaceuticals regarding its study of CPX-351, a special formulation of two standard chemotherapy drugs, to treat elderly patients with high-risk acute myeloid leukemia (AML), is a positive advance for patients with few options for effective treatment, The Leukemia & Lymphoma Society (LLS) said today.