In South Africa, leukaemia is the most prevalent of childhood cancers (24%). It is usually treated with chemotherapy, sometimes with radiotherapy and sometimes with biological therapy, which is available at a number of medical centres across South Africa.
But a new combination chemotherapy drug Vyxeos (daunorubicin and cytarabine) has been approved by the US Food and Drug Administration as the first treatment for certain high-risk types of acute myeloid leukaemia.
AML is an aggressive blood cancer that forms in the bone marrow. It starts from a single immature cell that becomes abnormal. Over time, several changes take place in that cell before it becomes malignant. Once it is malignant, the cell keeps producing large numbers of malignant daughter cells, some of which mature, and some of which remain as immature as the original abnormal cell.
“Vyxeos combines two commonly used chemotherapies into a single formulation that may help some patients live longer than if they were to receive the two therapies separately,” said Dr Richard Pazdur, director of the FDA’s Oncology Center of Excellence.
In a news release, the agency said more than 21 000 people will be diagnosed this year with AML, and more than 10 000 will die from it, according to projections from the US National Cancer Institute.
The new therapy is sanctioned for high-risk forms of newly-diagnosed therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC). People with either disease have a very low life expectancy, the FDA said.
Vyxeos was evaluated in clinical trials involving 309 people with either form of AML. Those given Vyxeos lived an average of 9.6 months, compared with 5.9 months among those who took an inactive placebo.
Some side effects
The therapy’s most common side effects included bleeding, fever, low white blood-cell count, rash, tissue swelling and nausea. Some users had episodes of serious allergic-like hypersensitivity reactions or dangerous bleeding, the agency said.
Women who are pregnant or breast-feeding shouldn’t take Vyxeos, the FDA added. Approval of the drug was granted to the Irish firm Jazz Pharmaceuticals.
It is not yet known if and when Vyxeos will be approved by the South African Medical Research Council and made available for use in this country.