Saturday, August 12, 2017

FDA approves two drugs for certain types of AML

A scanning electron 
microscope image 
from normal circulating 
human blood. – Wikipedia

CANCER DIGEST – Aug. 12, 2017 – The FDA approved two new drugs for treatment of specific types of acute myeloid leukemia (AML), a rapidly progressing cancer that forms in the bone marrow.

Vyxeos was approved for two types of AML, newly diagnosed therapy-related AML called t-AML, and myelodysplasia-related changes changes called ALM-MRC. 

In a press release, the FDA said this is the first approved treatment specifically for patients with certain types of high-risk AML. 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. 

FDA’s approval was based on studies of 309 patients with newly diagnosed t-AML or AML-MRC who were randomly assigned to a group receiving Vyxeos or a group that received the two drugs daunorubicin and cytarabine separately. The clinical trial compared how long patients survived from the date they started the therapy. Patients who received Vyxeos lived 9.6 months compared to 5.95 months for patients who received the treatments separately.

The second drug approved for AML is Idhifa (enasidenib) for the treatment of adults with relapsed AML or those whose disease had not responded to other treatments who have a specific genetic mutation. The drug is given in combination with the IDH2 test that identifies the mutation.

Idhifa works by blocking enzymes linked to the mutation that promotes cell growth. FDA approval was based on a study of 199 patients with relapsed or unresponsive AML who had the IDH2 mutation as detected by the test. The trial measured the percentage of patients with no evidence of disease and full recovery of blood counts (complete remission) and patients with no evidence of disease and partial recovery of blood counts.

After a minimum of 6 months of treatment 19 percent of patients experienced complete remission for a median of 8.2 months, meaning half of those patients had complete remissions longer than that and half for less than that. Another 4 percent of patients achieved a complete response for a median of 9.6 months. 

Of the 157 patients who required transfusions due to AML at the start of the study, 34 precent no longer required transfusions after treatment with Idhifa.  

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