New Pfizer EU approval offers first treatment option for leukaemia subtype

Pfizer has revealed that its drug Besponsa (inotuzumab ozogamicin) has received approval from the European Commission as a monotherapy for the treatment of adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL), making it the first and only antibody drug conjugate (ADC) available for patients with this type of leukaemia in the EU.

The decision includes patients with Philadelphia chromosome positive (Ph+) and negative (Ph-) relapsed or refractory B-cell precursor ALL, while those with Ph+ relapsed or refractory CD22-positive B-cell precursor ALL should have failed treatment with at least one tyrosine kinase inhibitor (TKI).

"The European Commission’s approval of BESPONSA represents an important milestone for patients, the oncology community and Pfizer," commented Andreas Penk, Regional President of Pfizer Oncology. "This is the first approval for Besponsa and provides patients in the EU, who are battling an especially hard-to-treat leukaemia, with a new treatment option beyond chemotherapy."

The EC’s decision was based on Phase 3 trial data in which showed that Besponsa met its primary endpoints of overall survival and complete response with or without haematologic recovery in 326 patients with with relapsed or refractory B-cell precursor ALL.

"Acute lymphoblastic leukemia that has recurred or is refractory following first-line therapy is a rare and rapidly progressive disease with poor prognosis," explained Professor David Marks from the Department of Haematology, University Hospitals Bristol NHS Foundation Trust, UK. "The approval of Besponsa (inotuzumab ozogamicin) provides a much needed treatment option for physicians and patients alike, that may help improve outcomes for some of the most vulnerable leukaemia patients in Europe."

Matt Fellows