Pfizer’s leukaemia drug Besponsa receives EU approval

Pfizer has announced that its new acute lymphoblastic leukaemia therapy Besponsa has been approved by the European Commission.

The inotuzumab ozogamicin treatment has been approved as a monotherapy for the treatment of adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukaemia, becoming the first and only antibody drug conjugate available for this form of cancer in Europe.

This indication includes the treatment of adults with Philadelphia chromosome-positive and negative relapsed or refractory cancers who have failed treatment with at least one tyrosine kinase inhibitor.

In the phase III INO-VATE ALL trial, it was shown that Besponsa offered safety and efficacy benefits compared to standard of care chemotherapy, with results from this study helping to support this regulatory decision.

Dr Andreas Penk, regional president for Pfizer Oncology, said: "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 company is also expecting an approval decision from the US Food and Drug Administration in the coming months.

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