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FDA Approves 2 New Treatments for AML in Older Adults & Patients with Comorbidities

The U.S. Food and Drug Administration (FDA) recently approved two new treatment options for certain people with acute myeloid leukemia (AML): Daurismo™ (glasdegib) and Venclexta® (venetoclax) in combination with other treatment. Both of these treatments are approved for use in people with AML who are 75 years or older, or who have other conditions (comorbidities) that make them unable to be treated with intensive chemotherapy.1,2

Why these approvals are important

AML is a blood cancer that can progress rapidly and causes an increased number of abnormal white blood cells in the bone marrow and blood stream. The cancerous cells can crowd out healthy blood cells, causing anemia, lowered platelets, and lowered white blood cells.3 AML is most commonly diagnosed in older adults, although it can sometimes occur in younger people or children.4 As a blood cancer that can progress rapidly, prompt treatment is important.3 Standard treatment for AML involves intensive chemotherapy, which can cause significant side effects and can become very toxic for the body. It is estimated that almost half of the adults currently diagnosed with AML do not received treatment because they cannot tolerate the intensive chemotherapy.2

These recent approvals by the FDA are meaningful because many patients, especially older patients, with AML cannot tolerate chemotherapy due to its toxicity. These new treatments provide another option for older patients or patients with other health conditions.

About venetoclax

Venetoclax was previously approved for use in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL). Venetoclax inhibits the protein oral B-cell lymphoma-2 (BCL-2), a protein that is found in large numbers on certain cancer cells and is involved in the cancer cell’s survival and resistance to chemotherapy. Venetoclax binds directly to this protein, weakening cancer cells. Venetoclax is used in combination with a chemotherapy agent, such as azacytidine, decitabine, or low-dose cytarabine.1,5

Possible side effects with venetoclax

The most common side effects experienced by patients receiving venetoclax in combination with azacytidine, decitabine, or low-dose cytarabine included nausea, diarrhea, low blood cell counts, constipation, fatigue, vomiting, swelling of the arms and/or legs (peripheral edema), pneumonia, shortness of breath, rash, abdominal pain, bleeding, sepsis, back or muscle pain, dizziness, cough, throat pain, fever, and low blood pressure.1

About glasdegib

The second FDA approval was for glasdegib, a targeted therapy that is classified as a hedgehog pathway inhibitor. By blocking the hedgehog pathway, glasdegib can slow or stop the cancer from growing.6 Glasdegib is approved for use in combination with low-dose cytarabine.2

Possible side effects with glasdegib

The most common side effects experienced by patients receiving glasdegib in clinical trials included low blood cell counts, fatigue, bleeding, fever, muscle pain, nausea, swelling of the arms and/or legs (peripheral edema), shortness of breath, decreased appetite, change in taste, pain or sores in the mouth or throat (mucositis), constipation and rash.2

  1. FDA approves venetoclax in combination for AML in adults. U.S. Food and Drug Administration. Available at Accessed 11/28/18.
  2. FDA approves new treatment for patients with acute myeloid leukemia. U.S. Food and Drug Administration. Available at Accessed 11/28/18.
  3. What is acute myeloid leukemia (AML)? American Cancer Society. Available at Accessed 11/28/18.
  4. Cancer stat facts: leukemia – acute myeloid leukemia. SEER (Surveillance, Epidemiology and End Results) Cancer Statistics Review, National Cancer Institute. Available at Accessed 11/28/18.
  5. Venclexta prescribing information. Available at Accessed 11/28/18.
  6. Glasdegib (Daurismo). OncoLink. Available at Accessed 11/28/18.