FDA Approves Scemblix for Chronic Myeloid Leukemia

People living with certain hard-to-treat types of chronic myeloid leukemia (CML) now have another treatment option. The U.S. Food and Drug Administration (FDA) has approved Scemblix® (asciminib), a kinase inhibitor.1-3

Scemblix is for adults with Philadelphia chromosome-positive CML in the chronic phase:1-3

  • Whom doctors have already treated with 2 or more tyrosine kinase inhibitors (TKIs)
  • With the T315I mutation (a type of gene change)

People with these types of CML may have serious side effects with other TKIs. Or, they may respond poorly to them.

Scemblix is the first FDA-approved treatment for CML that targets the ABL gene on the Philadelphia chromosome. A change in this gene leads to the development of CML.5

What are the ingredients in Scemblix?

The active ingredient in Scemblix is asciminib.2

How does Scemblix work?

Scemblix is a kinase inhibitor. This class of drugs blocks kinases (a type of protein) and helps keep cancer cells at bay. Kinase inhibitors also stop new blood vessels from growing, which tumors need to thrive.4

Evidence for Scemblix

Researchers are studying Scemblix in 2 separate clinical trials. One is for people with chronic phase CML who have taken 2 or more TKIs in the past. The other is for those who have CML with the T315I mutation.6

Scientists are looking at the major molecular response (MMR) of people taking part in the trials. Someone with an MMR has less of the BCR-ABL gene than those with untreated CML. A blood or bone marrow test shows how much of this gene is in your cells.6

In the study with those who have chronic phase CML previously treated with 2 or more TKIs, researchers recruited 233 people living with CML. They took either Scemblix or Bosulif (bosutinib), another kinase inhibitor. After 24 weeks of treatment, the MMR rate was:1

  • 25 percent in people who took Scemblix
  • 13 percent in people who took Bosulif

In the study with those who have CML with T315I mutation, researchers included 45 people with CML. They received 200 milligrams of Scemblix twice a day. The average treatment length was just over 2 years. Study results show:1

  • 42 percent reached MMR in 24 weeks
  • 49 percent reached MMR in 96 weeks

What are the possible side effects of Scemblix?

The most common side effects of Scemblix include:1

  • Infections of the sinuses and throat (upper respiratory tract)
  • Pain in the bones, joints, ligaments, muscles, and tendons
  • Fatigue
  • Nausea
  • Rash
  • Diarrhea

Lab tests may also show lower blood cell and higher triglycerides and enzyme results.1

These are not all the possible side effects of Scemblix. Talk to your doctor about what to expect when taking Scemblix. You also should call your doctor if you have any changes that concern you when taking Scemblix.

Things to know about Scemblix

The FDA has fully approved Scemblix for treating CML with the T315I mutation. For now, the drug has accelerated approval for chronic phase CML previously treated with 2 or more TKIs. The FDA may give accelerated approval to new drugs that treat a health condition with few or no other treatments. This means drugs like Scemblix can be sold sooner.1

Before beginning treatment with Scemblix, tell your doctor about all your health conditions and any other drugs, vitamins, or supplements.

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