FDA approves Onureg (azacitidine tablets) for acute myeloid leukemia

Summary: The Food and Drug Administration (FDA) has announced the approval of Onureg, a new oral formulation of a drug used for remission continuation therapy in adults with acute myeloid leukemia (AML). This drug is an oral form of the medication azacitidine (Vidaza) and will be used in the second stage of treatment for AML, after remission has been achieved with other forms of intensive induction chemotherapy. At this point in treatment, the goal is either to prevent relapse or to cure the cancer with a stem cell transplant. Onureg will be used to extend life in people who are not good candidates for stem cell transplant.

Dr. Dan's Takeaway: Onureg is a good addition to treatment for patients who are in remission but cannot receive a stem cell transplant. It is a once daily pill, and so is easy to take at home. In clinical trials, it extended life for 10 months longer than placebo, with the average patient surviving for over 2 years. Onureg kills both cancer cells and healthy immune cells, and is therefore associated with a risk of severe infections, such as pneumonia (8%). It is also very common to experience nausea, vomiting, and diarrhea, so it is important to talk to your doctor to make sure it is right for you.



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