Besponsa
What Besponsa is used for
Besponsa is indicated as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B cell precursor acute lymphoblastic leukaemia (ALL). Adult pPatients with Philadelphia chromosome positive (Ph+) relapsed or refractory B cell precursor ALL should have failed treatment with at least 1 tyrosine kinase inhibitor (TKI). Besponsa is indicated as monotherapy for paediatric patients 1 year and older with CD22-positive B cell precursor ALL: in first relapse after allo-haematopoietic stem cell transplant (HSCT); after any first relapse in patients with Very High Risk (VHR) disease (see section 5.1); after a second or greater relapse; and in those with refractory disease. Patients with Philadelphia chromosome positive (Ph+) disease should have exhausted relevant BCR-ABL targeting treatment options.
Approved use, as published by the European Medicines Agency.
What the labels mean
- Orphan medicine: for a rare disease (affecting no more than 5 in 10,000 people in the EU).
Key facts
- Brand
- Besponsa
- Active substance
- inotuzumab ozogamicin
- Disease area
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Medicine group
- Antineoplastic agents
- ATC code
- L01FB01
- Marketing authorisation holder
- Pfizer Europe MA EEIG
- Authorised in the EU since
- 2017
Official information
In the USA
Same active substance: Besponsa
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Besponsa used for?
Besponsa is indicated as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B cell precursor acute lymphoblastic leukaemia (ALL). Adult pPatients with Philadelphia chromosome positive (Ph+) relapsed or refractory B cell precursor ALL should have failed treatment with at least 1 tyrosine kinase inhibitor (TKI). Besponsa is indicated as monotherapy for paediatric patients 1 year and older with CD22-positive B cell precursor ALL: in first relapse after allo-haematopoietic stem cell transplant (HSCT); after any first relapse in patients with Very High Risk (VHR) dise…
What is the active substance in Besponsa?
Besponsa contains inotuzumab ozogamicin.
Who makes Besponsa?
The EU marketing authorisation holder is Pfizer Europe MA EEIG.
Is Besponsa an orphan medicine?
Yes. Besponsa is designated an orphan medicine in the EU, for a rare disease (Precursor Cell Lymphoblastic Leukemia-Lymphoma).
Source: European Medicines Agency medicines data (ema.europa.eu), reproduced with acknowledgement of the source. Page made 5 November 2026 by Satya Babu.
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