Besponsa - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation

inotuzumab ozogamicin

Opinion

On 26 March 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Besponsa. The marketing authorisation holder for this medicinal product is Pfizer Europe MA EEIG.

The CHMP adopted a new indication as follows:

Besponsa is indicated as monotherapy for the treatment of adults with relapsed or refractory CD22 positive B cell precursor acute lymphoblastic leukaemia (ALL). Patients 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 BCL-ABL targeting treatment options.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

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Note: New text in bold

CHMP post-authorisation summary of positive opinion for Besponsa (VR/0000257310)

Adopted Reference Number: EMADOC-1700519818-2985043

Key facts

• Name of medicine:
  Besponsa
• EMA product number:
  EMEA/H/C/004119
• Active substance:
  Inotuzumab ozogamicin
• International non-proprietary name (INN) or common name:
  inotuzumab ozogamicin
• Therapeutic area (MeSH):
  Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Anatomical therapeutical chemical (ATC) code:
  L01FX06
• Orphan:

  This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

• Marketing authorisation holder:
  Pfizer Europe MA EEIG
• Date of opinion:
  26/03/2026
• Status:
  Positive