How XOSPATA May Help

XOSPATA Was Compared to Chemotherapy

XOSPATA was studied in comparison to chemotherapy in people whose AML had come back or had not improved after previous treatment. People in the study were positive for a FLT3 mutation, as determined by a bone marrow or blood test.

The final set of results in the study compared the rate of overall survival in 247 people who had taken XOSPATA with 124 people who received chemotherapy.

The term overall survival refers to the length of time during the study that people stayed alive beyond the start of treatment.

XOSPATA May Help People Live Longer

In the study,
the median overall survival for people
who took XOSPATA was 9 months

6 months
with chemotherapy

People taking XOSPATA had a

36%

lower risk of death during the study compared with people receiving chemotherapy

Based on the results of the study,
it was estimated that:

37%

of people were alive at 1 year with XOSPATA

17%

of people with chemotherapy

19%

of people were alive at 2 years with XOSPATA

14%

of people with chemotherapy

Results may vary. Talk with your doctor about what this may mean for you.

 
Median: The middle value in a set of numbers, not the average.
Select Safety Information

XOSPATA may cause serious side effects including:

  • Changes in the electrical activity of your heart called QTc prolongation. QTc prolongation can cause irregular heartbeats that can be life-threatening. Your healthcare provider will check the electrical activity of your heart with a test called an electrocardiogram (ECG) before you start taking XOSPATA and during your treatment with XOSPATA. Tell your healthcare provider right away if you feel dizzy, lightheaded, or faint. The risk of QT prolongation is higher in people with low blood magnesium or low blood potassium levels. Your healthcare provider will do blood tests to check your potassium and magnesium levels before and during your treatment with XOSPATA.

Longer Remission Is Possible With XOSPATA

To determine how well XOSPATA works, doctors used different ways to measure how a person responded to treatment during the study. One of those methods was complete remission.

Complete remission means that no signs of leukemia cells are found in the blood or bone marrow, and blood counts have returned to normal. This does not mean that the cancer has been cured.

In the study,

14%

of people achieved complete remission with XOSPATA (35 out of 247 people)

11%

of people achieved complete remission with chemotherapy (13 out of 124 people)

People who achieved complete remission
continued to stay in remission for a median of

15 MONTHS with XOSPATA

15 months bar graph

vs a median of 2 months with chemotherapy

2 months bar graph

XOSPATA Helped Reduce the Need for Transfusions in Some People

During the study, a response to XOSPATA was also measured by how many people needed blood and/or platelet transfusions.

1 out of 3 people

who needed transfusions at the start of the study gained independence from transfusions for up to 8 weeks with XOSPATA (68 out of 197 people)

Results may vary. Talk with your doctor about what this may mean for you.

 
Platelet: A small, ring-shaped cell that helps to form clots in the blood in order to slow or stop bleeding and to help wounds heal.
Select Safety Information

XOSPATA may cause serious side effects including:

  • Inflammation of the pancreas (pancreatitis). Tell your healthcare provider right away if you have severe stomach (abdomen) pain that does not go away. This pain may happen with or without nausea and vomiting.