Besponsa (inotuzumab ozogamicin)
- Region
- 🇪🇺 EU
- Active substance
- inotuzumab ozogamicin
- Company
- Pfizer Europe MA EEIG
- Status
- Authorised
- Therapeutic area
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- CHMP opinion
- Thu 20 Apr 2017
- EU approval
- Wed 28 Jun 2017
- Designations
- Orphan
- Application
- EMEA/H/C/004119
- ATC
- L01FB01
- Official record
- www.ema.europa.eu
Indication
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.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.