> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Wyeth’s Besponsa Approved for Leukemia
- URL: https://www.fdaweb.com/wyeths-besponsa-approved-for-leukemia/
- Published: 2017-08-17T12:00:00.000Z
- Updated: 2026-09-14T22:41:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139409

FDA has approved Wyeth Pharmaceuticals’ Besponsa (inotuzumab ozogamicin) for treating adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). The approval was based on data from INO-VATE ALL (NCT01564784), a randomized (1:1), open label, international, multicenter study in 326 patients with Philadelphia chromosome-negative or Philadelphia chromosome-positive relapsed or refractory B-cell precursor ALL. Patients were required to have certain bone marrow blasts and to have received one or two previous induction chemotherapy regimens for ALL, an [agency release](http://links.govdelivery.com/track?type=click&enid=ZWFzPTEmbWFpbGluZ2lkPTIwMTcwODE3Ljc3MDg3NDAxJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDE3MDgxNy43NzA4NzQwMSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE3NDQxNjg0JmVtYWlsaWQ9ZGF2aWRAZmRhd2ViLmNvbSZ1c2VyaWQ9ZGF2aWRAZmRhd2ViLmNvbSZmbD0mZXh0cmE9TXVsdGl2YXJpYXRlSWQ9JiYm&&&100&&&https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm572131.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery) says.

  
“Of the initial 218 randomized patients, 35.8% of those who received inotuzumab ozogamicin experienced complete remission (CR) for a median 8.0 months and 89.7% of those patients achieved minimal residual disease (MRD)-negativity,” the agency says. “Of the patients who received chemotherapy, 17.4% experienced CR for a median 4.9 months and 31.6% of those patients achieved minimal residual disease MRD-negativity.”