FDA Priority Review for Pfizer investigational leukaemia drug
pharmafile | February 22, 2017 | News story | Research and Development, Sales and Marketing | EMA, FDA, Inotuzumab ozogamicin, Pfizer, priority review
Pfizer has announced that its leukaemia treatment inotuzumab ozogamicin has been accepted for Priority Review by the US Food and Drug Administration (FDA).
The investigational drug is an antibody-drug conjugate containing a monoclonal antibody CD22, a cell-surface antigen which occurs on 90% of B-cell malignancies. Pfizer is aiming to secure licensing for the therapy for the treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL) in adult patients.
The FDA’s reached its decision in part thanks to data generated from a 326-participant trial which showed that use of inotuzumab ozogamicin led to complete remission rate of 81% versus 29.4% for standard therapy. The drug also boasted median overall survival rates of 7.7 months and 5 months median progression-free survival against 6.7 and 1.8 months respectively.
“ALL that has recurred after, or is refractory to, first-line therapy is a rapidly progressing and deadly disease,” explained Mace Rothenberg, Chief Development Officer, Oncology, Pfizer Global Product Development. “Based on the positive results of the INO-VATE 1022 Phase 3 trial, we believe inotuzumab ozogamicin, if approved, represents a new treatment option for adult patients with relapsed or refractory B-cell precursor ALL.”
The drug is currently under review by the European Medicines Agency for the same indication.
Matt Fellows
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