Positive results from a Phase 3 clinical trial recently prompted the European Commission to approve Besponsa, Pfizer Inc.’s new immunotherapy treatment for patients suffering from B-cell precursor acute lymphoblastic leukemia, the pharmaceutical said in a release.
Besponsa (inotuzumab ozogamicin) is regarded as a game-changer because it stimulates the body’s immune system to pinpoint malignant cells without harming their healthy counterparts, a downside of traditional chemotherapy, Pfizer said in the release.
Besponsa's efficacy was demonstrated in a trial where it bested traditional chemotherapy at targeting both Philadelphia chromosome positive and negative forms of B-cell leukemia. It was effective in cases that had either gone dormant but still was detectable or had recurred after earlier successful treatment.
“The European Commission’s approval of Besponsa represents an important milestone for patients, the oncology community and Pfizer,” Dr. Andreas Penk, Pfizer oncology’s regional president, said in the release. “This is the first approval for Besponsa and provides patients in the EU who are battling an especially hard-to-treat leukemia with a new treatment option beyond chemotherapy.”
Hematology professor David Marks of the U.K.’s University Hospitals Bristol NHS Foundation Trust, said in the release that by the time acute lymphoblastic leukemia is driven dormant or recurs, most treatment options have been exhausted.
This form of the disorder is “a rare and rapidly progressive disease with poor prognosis,” Marks said in the release. “The approval of Besponsa provides a much needed treatment option for physicians and patients alike, that may help improve outcomes for some of the most vulnerable leukemia patients in Europe.”
In the U.S., Besponsa is undergoing accelerated review by the Food and Drug Administration, with full approval anticipated in August 2017.