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news.Pfizer has secured approval from the US Food and Drug Administration (FDA) for its Besponsa (inotuzumab ozogamicin) to treat adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
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The FDA assessed and approved Besponsa under the breakthrough therapy designation and priority review programs.
Besponsa is a targeted therapy, which is believed to work by binding to B-cell ALL cancer cells that express the CD22 antigen, enabling to block the growth of cancerous cells.
Besponsa’s approval was based on results from the Phase 3 Ino-Vate ALL trial.
The trial is a randomized, open-label, international and multicenter study that assessed the safety and efficacy of Besponsa against Investigator’s choice of chemotherapy in 326 adult patients with relapsed or refractory B-cell ALL.1
In July, Pfizer also secured European Commission approval for Besponsa as monotherapy to treat adults with relapsed or refractory CD22-positive B-cell precursor ALL.
Pfizer Oncology global president Liz Barrett said: “The approval of Besponsa is an important step forward for adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia, a rare disease that can be fatal within a matter of months if left untreated.
“Besponsa will help address a significant need for new treatment options in B-cell acute lymphoblastic leukemia, and may help more patients reach stem cell transplant, which provides the best chance for long term remission.”
FDA’s Oncology Center of Excellence director Dr Richard Pazdur said: “For adult patients with B-cell ALL whose cancer has not responded to initial treatment or has returned after treatment, life expectancy is typically low.”
Image: Pfizer world headquarters in Manhattan, New York. Photo: courtesy of Coolcaesar.