Pfizer attains FDA breakthrough approval for leukemia drug

Besponsa improved multiple efficacy measures, including rates of hematologic remission.
Besponsa improved multiple efficacy measures, including rates of hematologic remission. | File photo

An innovative treatment for certain types of acute lymphoblastic leukemia (ALL).1 — Pfizer’s Besponsa (inotuzumab ozogamicin) — recently obtained approval from the U.S. Food and Drug Administration via its Breakthrough Therapy designation and Priority Review programs.

“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,” Liz Barrett, global president of Pfizer Oncology, said.

The status followed results from a Phase 3 trial study comparing the antibody-based drug to chemotherapy in adults with relapsed or refractory B-cell ALL.1 — demonstrating 81 percent versus 29 percent remission rates respectively.

“Based on the results seen in the ... trial, Besponsa improved multiple efficacy measures, including rates of hematologic remission, MRD-negativity and stem cell transplantation,” Dr. Hagop Kantarjian, lead study investigator and a professor at The MD Anderson Cancer Center, said. “I look forward to seeing the impact this important new therapy may have on my patients.”

Product labeling for Besponsa includes warnings for risks and adverse reactions. Pfizer strives to help all patients gain access to its products regardless of financial or health care insurance status through patient assistance programs.

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