The Food and Drug Administration has given Pfizer's Besponsa the go-ahead to be used by adults who have relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
The FDA's decision on Besponsa came from outcomes of the Phase 3 INO-VATE ALL study on how well Besponsa worked and how secure it would be for using to fight relapsed or refractory B-cell precursor acute lymphoblastic leukemia, Pfizer said in a release.
In the testing, 81 percent of people fighting relapsed or refractory B-cell precursor acute lymphoblastic leukemia with Besponsa had the disease go away entirely, while just 29 percent of those people who used chemo had the disease go away entirely. Of that 81 percent, the people who took Besponsa had more instances of not having leukemia cells stay in the body after they took the medicine, while those who took the chemo had more instances of having leukemia cells stay in the body after they took the chemo, the release said.
The FDA used its Breakthrough Therapy classification and Priority Review designation to give Besponsa the thumbs-up.
