What is Besponsa (inotuzumab ozogamicin) for?

Besponsa (inotuzumab ozogamicin) is a CD22-directed antibody-drug conjugate (ADC) used to treat adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)^1,2.

How does Besponsa (inotuzumab ozogamicin) work?

The active substance in Besponsa, inotuzumab ozogamicin, is a monoclonal antibody (a type of protein) that has been linked to a small molecule - N-acetyl-gamma-calicheamicin dimethylhydrazide - a cytotoxic agent that once activated provokes the death of cancer cells. The monoclonal antibody has been designed to recognise and attach to CD22 on the cancerous B cells. Once attached, the medicine is taken up by the cell where the cytotoxic agent becomes active, causing breaks in the cell’s DNA and thereby killing the cancer cell³.

Where has Besponsa (inotuzumab ozogamicin) been approved?

Besponsa (inotuzumab ozogamicin) was approved as a monotherapy for relapsed or refractory CD22-positive B cell precursor acute lymphoblastic leukaemia (ALL)^1,2 by:

• European Medical Agency (EMA), European Union, June 29, 2017³

• Food and Drug Administration (FDA), USA, August 17, 2017⁴

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

How is Besponsa (inotuzumab ozogamicin) taken?

The standard dosage is:

• Cycle 1 (21 days): Cycle 1 is 3 weeks in duration but may be extended to 4 weeks if the patient achieves a complete remission (CR) or complete remission with incomplete hematologic recovery (CRi), and/or to allow recovery from toxicity.

• Day 1: 0.8 mg/m²

• Day 8 : 0.5 mg/m²

• Day 15: 0.5 mg/m²

• Following cycles (28 days)

• for patients who have achieved CR or CRi

• Day 1: 0.5 mg/m²

• Day 8: 0.5 mg/m²

• Day 15: 0.5 mg/m²

• for patients who have not achieved CR or CRi

• Day 1: 0.8 mg/m2

• Day 8: 0.5 mg/m2

• Day 15: 0.5 mg/m2

Prior to all infusions, patients need to be pre-medicated with a corticosteroid, antipyretic, and antihistamine^1,2.

Besponsa (inotuzumab ozogamicin) is given as an infusion into a vein lasting for at least one hour. The infusions are given on days 1, 8 and 15 of a 3 or 4-week treatment cycle. The treatment may be interrupted or the dose may be reduced if the patient develops certain serious side effects³.

Patients in whom Besponsa (inotuzumab ozogamicin) works well should receive 2 or 3 cycles, after which they can have a stem cell transplant to replace their bone marrow, the only curative treatment. Patients whose treatment works well, but who are not going to receive a stem cell transplant, may receive up to a maximum of 6 cycles of treatment. In patients who do not respond to treatment, Besponsa (inotuzumab ozogamicin) should be stopped after 3 cycles³.

Complete information about Besponsa (inotuzumab ozogamicin) dosage and administration can be found in the resources section^1,2.

Note: Consult your treating doctor for personalised dosing.

Are there any known adverse reactions or side effects of Besponsa (inotuzumab ozogamicin)?

Common adverse reactions

The most common adverse reactions (≥ 20%) listed in the prescribing information include^1,2:

• Thrombocytopenia (low level of platelets)
• neutropenia (low level of neutrophils, a type of white blood cell)
• infection
• anemia (low levels of red blood cells)
• Leukopenia (low level of number of circulating neutrophil granulocytes)
• fatigue
• hemorrhage
• Pyrexia (fever)
• Nausea (feeling sick)
• headache
• febrile neutropenia (fever in concomitance with a level of neutrophils, a type of white blood cell)
• transaminases increased (liver damage)
• abdominal pain
• gamma-glutamyltransferase increased (high level of liver enzymes)
• hyperbilirubinemia (high levels of bilirubin, a substance made by the breakdown of red blood cells)
• Serious adverse reactions

The serious adverse reactions listed in the prescribing information include^1,2:

• infection

• febrile neutropenia (fever in concomitance with a level of neutrophils, a type of white blood cell)

• haemorrhage

• abdominal pain

• pyrexia (fever)

• Linver injury: hepatic veno-occlusive disease (VOD)/ Sinusoidal obstruction syndrome (SOS)

• fatigue (tiredness)

• heart rhythm disorder: QT interval prolongation

Use in specific populations

Besponsa (inotuzumab ozogamicin) can be fatal for a fetus, it is advised to avoid pregnancies and breast feeding^1,2.

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information^1,2.