{"id":1470,"date":"2017-08-07T20:35:15","date_gmt":"2017-08-08T04:35:15","guid":{"rendered":"https:\/\/www.sfj-pharma.com\/?p=795"},"modified":"2021-05-13T14:35:40","modified_gmt":"2021-05-13T22:35:40","slug":"besponsa-fda-approval-release","status":"publish","type":"post","link":"https:\/\/www.sfj-pharma.com\/besponsa-fda-approval-release\/","title":{"rendered":"BESPONSA FDA Approval Release"},"content":{"rendered":"PFIZER RECEIVES U.S. FDA APPROVAL FOR BESPONSA\u00ae (INOTUZUMAB OZOGAMICIN)<\/h3>\n
August 17, 2017<\/strong>
\nBESPONSA is the first and only CD22-directed antibody-drug conjugate indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia<\/p>\nNEW YORK–(BUSINESS WIRE)– Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved BESPONSA\u00ae (inotuzumab ozogamicin) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).1 BESPONSA was reviewed and approved under the FDA\u2019s Breakthrough Therapy designation and Priority Review programs.<\/p>\n
\u201cThe 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,\u201d said Liz Barrett, global president, Pfizer Oncology. \u201cBESPONSA 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. We\u2019re proud to build on our continued commitment to patients with hematologic malignancies, and will continue our work to find new treatments in acute lymphoblastic leukemia and other blood cancers.\u201d<\/p>\n