Jazz Pharmaceuticals has received Health Canada’s approval for Vyxeos (daunorubicin and cytarabine liposome) injection to treat a type of Acute Myeloid Leukemia (AML).
The drug is indicated for adults with newly diagnosed therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC).
Vyxeos belongs to the antineoplastics class of medicines, which are used to treat cancer as they prevent the development of a neoplasm or a tumour.
The drug is composed of two medicinal ingredients, including daunorubicin and cytarabine, which are packaged in tiny particles known as liposomes.
Delivering active ingredients in liposomes would help the drug to stay longer in the body, facilitating it to kill the cancer cells.
Vyxeos is the first product to be developed using the company’s CombiPlex technology platform, which enables the design, rapid evaluation and delivery of various therapies.
Jazz Pharmaceuticals Canada general manager Paul Petrelli said: “As a company dedicated to bringing life-changing medicines to market and redefining possibilities, the approval of Vyxeos in Canada represents Jazz’s promise of putting patients first.
“Vyxeos is an important example of how we meet the needs of the haematology and the oncology communities by offering a treatment that may extend life for high-risk AML patients.”
The Health Canada approval of Vyxeos is based on results from a Phase 3 study in 309 adults, aged between 60 and 75 years, with newly diagnosed t-AML or AML-MRC.
In the Phase 3 trial, Vyxeos showed superior improvement in overall survival compared to the current conventional treatment group, which is the primary endpoint of the study.
Treatment using Vyxeos demonstrated a median overall survival of 9.6 months compared with 6.0 months for the current conventional treatment.
AML is a rare cancer type that affects the bone marrow and the blood and progresses rapidly if not treated. Both t-AML and AML-MRC are considered high-risk AML.
T-AML is caused by previous therapeutic treatments while AML-MRC is a result of certain changes in the bone marrow, the spongy tissue inside the bones.
Hamilton Health Sciences Juravinski Cancer Centre clinical haematologist Brian Leber said: “Vyxeos is not only an effective treatment option but a significant advance by providing this patient population with a chemotherapy agent that takes less time to administer and provides a better chance at survival than our standard current treatment for high-risk AML.”
