The U.S. Food and Drug Administration (FDA) has approved a new all-oral treatment option for some people with acute myeloid leukemia (AML).
The treatment combines a tablet called decitabine and cedazuridine (brand name Inqovi) with another medicine, venetoclax. It is approved for adults who are newly diagnosed with AML and are either age 75 or older, or have other health conditions that make standard intensive chemotherapy too difficult to tolerate.
In a clinical study of 101 patients, about 4 in 10 people (41.6%) had their cancer go into complete remission, meaning no signs of leukemia were detected after treatment. For many patients, responses happened within about two months. At the time of the analysis, many responses were ongoing.
This treatment may be an important option because it can be taken by mouth, potentially reducing the need for frequent hospital visits compared with traditional chemotherapy.
As with many leukemia treatments, side effects can occur. The most important risks include low blood cell counts (which can increase the risk of infection, bleeding, or fatigue) and possible harm to an unborn baby if taken during pregnancy.
The treatment is given in 28-day cycles. Patients take one tablet daily for the first five days of each cycle, along with venetoclax, and continue as long as the treatment is working and side effects are manageable.
This approval was part of Project Orbis, a program that allows the FDA to work with international regulators to review cancer treatments more quickly.
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