Besponsa
Besponsa ingredients
| Active ingredient | Strength |
|---|---|
| Inotuzumab Ozogamicin | .25 mg/mL |
What Besponsa is used for
The FDA lists the approved uses on the official label (below). In the EU, inotuzumab ozogamicin is approved as Besponsa 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.
EU wording from the European Medicines Agency; US approved uses can differ.
Key facts
- Brand
- Besponsa
- Generic name
- Inotuzumab ozogamicin
- Made by
- Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
- Forms
- Injection, Powder, Lyophilized, For Solution
- Given
- Intravenous
- Drug class
- CD22-directed Immunoconjugate
- FDA approval
- Biologic licence (BLA) BLA761040
- On the US market since
- 2017
Official information
- Besponsa prescribing information (FDA label) on DailyMed
- MedlinePlus drug information (search for Inotuzumab ozogamicin)
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?
Besponsa (Inotuzumab ozogamicin) is a cancer medicine made by Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc., approved by the US FDA.
What are the ingredients of Besponsa?
Besponsa contains Inotuzumab Ozogamicin (.25 mg/mL).
Is Besponsa approved in Europe?
The same active substance is approved in the EU as Besponsa.
From the FDA National Drug Code directory (open.fda.gov, public domain) and the European Medicines Agency medicines list. Page made 5 November 2026 by Satya Babu.
← All specialty medicines, USA