Supplemental New Drug Application Submitted For Potential Acute Myeloid Leukemia Treatment

According to a story from PR Newswire, the biopharmaceutical company AbbVie has recently announced that it has sent a supplemental New Drug Application to the FDA for its product venetoclax, which is to be used with either a hypomethylating agent or a low dosage of cytarabine. The drug is intended to treat patients with acute myeloid leukemia who are otherwise unable to receive treatment with intensive chemotherapy.

About Acute Myeloid Leukemia

Acute myeloid leukemia is a type of blood cancer that affects the myeloid blood cells, and it causes the rapid growth of abnormal cells that begin to accumulate in the blood and bone marrow. This has an affect on the activity and function of normal blood cells as well. There are several risk factors for acute myeloid leukemia, including prior chemotherapy, other blood disorders, radiation exposure, and genetic susceptibility; the cancer has been known to run in families. This cancer progresses quickly and can be lethal in just a few weeks without treatment. Symptoms of acute myeloid leukemia include bruising and bleeding easily, shortness of breath, fatigue, and heightened risk of infection. In the US, the five year survival rate is just 27 percent. To learn more about acute myeloid leukemia, click here.

About Venetoclax

For people that are not qualified for intense chemotherapy treatment, there are effectively no treatment options that can promise prolonged survival; most patients that can’t get chemo survive from five to ten months after diagnosis. Older, less healthy patients are less likely to qualify for chemo. Venetoclax has the potential to offer a more effective option for these patients. 

Venetoclax has also received a couple of Breakthrough Therapy designations for the treatment of acute myeloid leukemia. Breakthrough Therapy designation is reserved for therapies that are meant to treat serious, life-threatening diseases and display the potential to offer major advantages over currently available treatments in preliminary data.

If the drug gains approval, it will be available to treat not just acute myeloid leukemia, but chronic lymphocytic leukemia as well; venetoclax recently received a label expansion for treating this type of cancer in patients who had tried at least one previous therapy.


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