Xpovio Receives Accelerated Approval for Diffuse Large B-Cell Lymphoma

The U.S. Food and Drug Administration (FDA) has approved Xpovio for the treatment of diffuse large B-cell lymphoma. Xpovio (selinexor) is for adults with refractory or relapsed diffuse large B-cell lymphoma. This is lymphoma that has come back after past treatment or that has not responded to other treatment options. Xpovio is for people who have tried at least 2 other treatments for their diffuse large B-cell lymphoma.

Xpovio is also for people with relapsed or refractory multiple myeloma who have tried at least 4 other treatments. In this group, Xpovio is taken with another drug called dexamethasone.

How does Xpovio work?

Xpovio belongs to a class of drugs called nuclear export inhibitors. It targets a protein called exportin 1 in cells. Exportin 1 plays a role in how other proteins and components move around inside the cell. When this movement is blocked, it can become hard for cells to carry out their normal functions.

When proteins that help the cell grow and divide are blocked from traveling where they need to go, the cells will die. If this process is targeted in cancer cells using Xpovio, cancer growth may be slowed or stopped.

Xpovio in clinical trials

Xpovio received accelerated approval after the results from a clinical trial were promising. The study involved adults with diffuse large B-cell lymphoma who had tried at least 2 to 5 other treatment options.

Overall, almost 30 percent of all study participants had responded to the drug. Additionally, 13 percent had a complete response. Of those who responded at least partially to the drug, almost 40 percent had a response that lasted at least 6 months, and 15 percent had a response that lasted at least a year. These results suggest that Xpovio may be helpful in slowing the spread of cancer in certain individuals who are not responding to other drugs.

What are the side effects of Xpovio?

The side effects of Xpovio may vary based on what the drug is being used for. In diffuse large B-cell lymphoma, the most common side effects are:

• Fatigue
• Nausea, vomiting, decrease in appetite, and weight loss
• Constipation or diarrhea
• Fever
• Low blood cell counts including red blood cells and white blood cells
• Low sodium levels in the blood

This is not a complete list of all possible side effects of Xpovio. Ask your doctor for more information.

Things to know about Xpovio

Xpovio can lower the number of red and white blood cells in the body. This can lead to an increased risk of infection. Xpovio can lower the number of platelets in the body as well. Low numbers of platelets can increase a person’s risk of serious bleeding.

Xpovio can cause severe gastrointestinal upset. Some people will need to take medicines to help reduce these side effects in order to keep taking Xpovio. Xpovio may also cause neurological side effects like dizziness or changes in mental status. Certain activities, like driving, may need to be avoided until these side effects resolve.

Tell your doctor about any other drugs, vitamins, or supplements you are taking. This includes over-the-counter drugs.

Xpovio may harm an unborn baby. Because of this, effective birth control is needed while taking the drug. Your doctor can help you and your partner understand what is needed if one of you could become pregnant. Xpovio may also pass through breast milk, so women taking Xpovio are advised not to breastfeed.

Read the prescribing information to learn more about Xpovio.¹