EC approves Pfizer’s Besponsa for ALL

Pfizer Inc. (NYSE:PFE) said the European Commission approved an MAA for Besponsa inotuzumab ozogamicin as monotherapy to treat relapsed or refractory CD22-positive, B cell precursor acute lymphoblastic leukemia. In patients with Philadelphia chromosome-positive (Ph+) ALL, the approval is limited to patients that have failed treatment with at least one tyrosine kinase inhibitor (TKI).

Earlier this year, FDA accepted and granted Priority Review to a BLA for Besponsa in the indication. Its PDUFA date is in August (see BioCentury Extra, Feb. 21). The product has breakthrough therapy and Orphan Drug designations in the U.S. to treat ALL and Orphan Drug status in the EU to treat B cell ALL...