EU CHMP recommends approval of Besponsa (inotuzumab ozogamicin) for treating acute lymphoblastic leukaemia- Pfizer
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Besponsa (inotuzumab ozogamicin), from Pfizer, intended for the treatment of adults with acute lymphoblastic leukaemia. Besponsa has been shown to increase the proportion of patients who have complete remission and molecular remission and to delay the progression of disease. The most common side effects are thrombocytopenia, neutropenia, anaemia, leucopenia, infection, haemorrhage and venoocclusive liver disease/sinusoidal obstruction syndrome.
The full indication is: "Besponsa is indicated as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B cell precursor acute lymphoblastic leukaemia (ALL). Adult 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)". It is proposed that Besponsa be prescribed by physicians experienced in treating cancer.
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