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Home Industry News Pfizer’s leukaemia drug Besponsa receives CHMP backing

Pfizer’s leukaemia drug Besponsa receives CHMP backing

25th April 2017

Pfizer has announced that its new leukaemia drug Besponsa has been recommended for European approval by the Committee for Medicinal Products for Human Use (CHMP).

The European Medicines Agency committee has endorsed the drug as a monotherapy for the treatment of adults with relapsed or refractory CD22-positive B-cell precursor Philadelphia chromosome-negative and positive acute lymphoblastic leukaemia (ALL) who have previously failed treatment with at least one tyrosine kinase inhibitor.

An antibody-drug conjugate designed to bind to the CD22 receptor present on the leukaemia cells of most patients with ALL, Besponsa works by delivering a potent toxin called calicheamicin into those cells to limit their growth.

The positive CHMP opinion was based on the strong safety and efficacy data generated for the drug in the 326-patient INO-VATE 1022 study.

Dr Mace Rothenberg, chief development officer for oncology at Pfizer's global product development unit, said: "The positive results of the INO-VATE 1022 phase III trial provide strong evidence of the important role Besponsa may have versus commonly used chemotherapy regimens used in this situation."

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