HOW BESPONSA® (INOTUZUMAB OZOGAMICIN) WORKS
How is BESPONSA different from chemotherapy?
  • BESPONSA is a type of medicine called an antibody-drug conjugate. BESPONSA is designed to find and attach to a specific protein, called CD22, found on leukemia cells
  • Once BESPONSA attaches to the CD22 protein, it enters the cell to deliver the drug, causing cell death
  • By specifically targeting CD22, BESPONSA may offer different benefits and tolerability than chemotherapy
Why might BESPONSA be right to treat acute lymphoblastic leukemia (ALL)?
  • The CD22 protein is present on leukemia cells in over 90% of patients with ALL, as well as on normal B cells, but is not present on most other types of healthy cells

BESPONSA is the first and only therapy approved to target CD22, a specific protein that occurs on the surface of ALL cells.

HOW OTHER PATIENTS RESPONDED
How was BESPONSA studied?
  • BESPONSA was evaluated versus chemotherapy in a large, global clinical trial in 326 adults with relapsed or refractory ALL
  • BESPONSA was studied in patients who were Philadelphia chromosome (Ph)–positive or Ph–negative in first or second relapse, or who were refractory to their previous treatment

HELPFUL TERMS

Remission: Remission means that no leukemia cells can be seen when looking at bone marrow under a microscope. Remission rates include both complete remission (CR) and complete remission with incomplete hematologic recovery (CRi).

  • CR means you are in remission, and that blood counts are in normal ranges
  • CRi also means you are in remission, but that some blood counts are not yet back within normal ranges

MRD-negative remission: Once you have achieved remission, additional measurements can be taken using advanced tests that can detect minuscule amounts of leukemia cells that can’t be seen under a microscope.

  • A minimal residual disease–negative (MRD-negative) remission means that no remaining leukemia cells can be detected

Length of remission: The period of time that patients are in a remission (either CR or CRi).

Median: The midpoint in a range of numbers, where exactly half of the numbers are below and half of the numbers are above that point.

The FDA approval of BESPONSA was based on results from the clinical trial that showed BESPONSA improved the rate of CR, the median length of CR, and the rate of MRD-negative CR versus chemotherapy.
What were the results with BESPONSA compared to chemotherapy?

More Patients Achieved Remission

There was no difference found in the median length of time patients lived after treatment with BESPONSA compared to chemotherapy.
POSSIBLE SIDE EFFECTS

BESPONSA is associated with a risk of liver problems and increased risk of death after stem cell transplant. BESPONSA can cause liver problems that can be severe, life-threatening, or fatal, including a condition called veno-occlusive disease (VOD). This condition can occur during treatment with BESPONSA or following subsequent treatment with a stem cell transplant. This condition was more common in patients who had elevated liver tests or who received dual alkylating agents in preparation for their stem cell transplant. Patients may be at a higher risk of VOD if they:

  • Receive a stem cell transplant after treatment with BESPONSA
  • Have previously received a stem cell transplant
  • Have ongoing or a history of liver problems
  • Are of older age
  • Received multiple treatments for their ALL prior to BESPONSA
  • Receive a greater number of BESPONSA treatment cycles
Serious side effects

BESPONSA may cause serious side effects that can be severe, life-threatening, or even lead to death. These include:

  • Liver problems, including a condition called hepatic veno-occlusive disease (VOD)
  • Increased risk of death after stem cell transplant
  • Low blood cell counts
  • Infusion-related reactions
  • Heart problems
  • Harm to an unborn baby
Common side effects

The most common side effects experienced with BESPONSA were:

  • Low platelet counts (thrombocytopenia)
  • Fatigue
  • Low white blood cell counts with and without fever (neutropenia, febrile neutropenia, and leukopenia)
  • Infection
  • Bleeding
  • Pain in the abdomen
  • Fever
  • Nausea
  • Headache
  • Low red blood cell counts (anemia)
  • Increases in lab tests measuring liver function
Tell your doctor about all of your medical conditions, including if you:
  • Have a history of liver problems, liver disease, or a condition called VOD
  • Have an infection
  • Have ever experienced symptoms such as fever, chills, rash, or breathing problems during or shortly after the BESPONSA infusion
  • Have heart problems, including a condition called QT prolongation
  • Are pregnant, plan to become pregnant, or if pregnancy is suspected while taking BESPONSA. Avoid becoming pregnant during treatment with BESPONSA. BESPONSA can cause harm to an unborn baby
    • Females who are able to become pregnant should use effective contraception during treatment with BESPONSA and for at least 8 months after the last dose
    • Males of reproductive potential should use effective contraception during treatment with BESPONSA and for at least 5 months after the last dose
  • Are breastfeeding or plan to breastfeed. Avoid breastfeeding during treatment with BESPONSA and for at least 2 months after the final dose
Call your doctor right away if you experience any of the signs and symptoms associated with the following side effects:
  • Liver problems, including a condition called VOD: Rapid weight gain, yellowing of the whites of the eyes, or abdominal swelling that may be painful
    • The risk of developing VOD is increased after receiving treatment with BESPONSA
  • Low blood cell counts: Signs and symptoms of infection (for example, redness or swelling), unexpected bleeding or bruising, blood in your urine or stools, or fever
  • Signs and symptoms of infection
  • Infusion-related reactions: Fever, chills, rash, or breathing problems during or following the BESPONSA infusion
  • Heart problems: Dizziness, lightheadedness, or fainting, or very slow, very fast, or abnormal heartbeats
These are not all the possible side effects of BESPONSA. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. For more information, ask your doctor or pharmacist.

IMPORTANT SAFETY INFORMATION AND INDICATION

WARNING: RISK OF LIVER PROBLEMS AND INCREASED RISK OF DEATH AFTER STEM CELL TRANSPLANT

BESPONSA can cause liver problems that can be severe, life-threatening, or fatal, including a condition called veno-occlusive disease (VOD). This condition can occur during treatment with BESPONSA or following subsequent treatment with a stem cell transplant. This condition was more common in patients who had elevated liver tests or who received dual alkylating agents in preparation for their stem cell transplant. Patients may be at a higher risk of VOD if they:

  • Receive a stem cell transplant after treatment with BESPONSA
  • Have previously received a stem cell transplant
  • Have ongoing or a history of liver problems
  • Are of older age
  • Received multiple treatments for their ALL prior to BESPONSA
  • Receive a greater number of BESPONSA treatment cycles

Your doctor should perform liver tests periodically during treatment, and may modify or stop your treatment with BESPONSA.

Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

BESPONSA may cause serious side effects, including:

  • Liver problems: Call your doctor right away if you experience rapid weight gain, yellowing of the whites of the eyes, or abdominal swelling that may be painful. The risk of developing VOD is increased after receiving treatment with BESPONSA. Discuss with your doctor the benefit/risk of BESPONSA treatment if you have a prior history of VOD or serious ongoing liver disease
  • Increased risk of death after stem cell transplant: Call your doctor right away if you experience any signs and symptoms of infection or liver problems. There is an increased risk of death due to infection and VOD after receiving BESPONSA
  • Low blood cell counts: Low blood cell counts and complications of low blood cell counts, including bleeding and infections, which may be severe, life-threatening, and fatal, have occurred with BESPONSA. Call your doctor right away if you experience signs and symptoms of infection (for example, redness, swelling), unexpected bleeding or bruising, blood in your urine or stools, or fever
  • Infusion-related reactions: Inform your doctor right away if you experience fever, chills, rash, or breathing problems during or following your BESPONSA infusion
  • Heart problems: Call your doctor right away if you feel dizzy, lightheaded, or faint or have very slow, very fast, or abnormal heartbeats. Tell your doctor about all the medicines you take

Before taking BESPONSA, tell your doctor about all of your medical conditions, including if you:

  • Have liver disease or a history of liver problems
  • Have an infection
  • Have ever experienced symptoms such as fever, chills, rash, or breathing problems during or shortly after your BESPONSA infusion
  • Have heart problems, including an event of QT prolongation
  • Are pregnant, plan to become pregnant, or if pregnancy is suspected while taking BESPONSA. Avoid becoming pregnant during treatment with BESPONSA. BESPONSA can cause harm to an unborn baby
    • Females who are able to become pregnant should use effective contraception during treatment with BESPONSA and for at least 8 months after the last dose
    • Males of reproductive potential should use effective contraception during treatment with BESPONSA and for at least 5 months after the last dose
  • Are breastfeeding or plan to breastfeed. Avoid breastfeeding during treatment with BESPONSA and for at least 2 months after the final dose

Common Side Effects of BESPONSA

The most common side effects are low platelet counts (thrombocytopenia), low white blood cell counts with and without fever (neutropenia, febrile neutropenia, and leukopenia), infection, low red blood cell counts (anemia), fatigue, bleeding, fever, nausea, headache, increases in lab tests measuring liver function, and pain in the abdomen.

These are not all of the possible side effects of BESPONSA. Tell your doctor if you have any side effect that bothers you or that does not go away. For more information, ask your doctor or pharmacist.

INDICATION

BESPONSA® (inotuzumab ozogamicin) is a prescription medicine used to treat adults with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL). It is not known if BESPONSA is safe and effective in children under 18 years of age.

Please see Full Prescribing Information, including BOXED WARNING.