{"id":7439,"date":"2017-08-17T19:54:00","date_gmt":"2017-08-18T03:54:00","guid":{"rendered":"https:\/\/www.sfj-pharma.com\/?p=7439"},"modified":"2021-05-13T13:53:17","modified_gmt":"2021-05-13T21:53:17","slug":"fda-approves-inotuzumab-ozogamicin-for-relapsed-or-refractory-b-cell-precursor-all","status":"publish","type":"post","link":"https:\/\/www.sfj-pharma.com\/fda-approves-inotuzumab-ozogamicin-for-relapsed-or-refractory-b-cell-precursor-all\/","title":{"rendered":"FDA approves inotuzumab ozogamicin for relapsed or refractory B-cell precursor ALL"},"content":{"rendered":"\r\n<p>On Aug. 17, 2017, the U.S. Food and Drug Administration approved inotuzumab ozogamicin (BESPONSA, Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).<\/p>\r\n\r\n\r\n\r\n<p>&nbsp;<\/p>\r\n\r\n\r\n\r\n<p>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 \u22655% bone marrow blasts and to have received one or two previous induction chemotherapy regimens for ALL. Patients with Philadelphia chromosome positive B cell precursor ALL were required to have disease that failed treatment with at least one tyrosine kinase inhibitor and standard chemotherapy.\u00a0<br \/><br \/>Patients were randomized to receive inotuzumab ozogamicin (n=164) or investigator\u2019s choice of chemotherapy (n=162). 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. 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.\u00a0<br \/><br \/>The most common adverse reactions occurring in greater than 20% of patients were thrombocytopenia, neutropenia, infection, anemia, leukopenia, fatigue, hemorrhage, pyrexia, nausea, headache, febrile neutropenia, transaminases increased, abdominal pain, gamma-glutamyltransferase increased, and hyperbilirubinemia. The most common (\u22652%) adverse reactions reported as the reason for permanent discontinuation were infection, thrombocytopenia, hyperbilirubinemia, transaminases increased, and hemorrhage.<\/p>\r\n\r\n\r\n\r\n<p>&nbsp;<\/p>\r\n\r\n\r\n\r\n<p>For the first cycle, the recommended dose of inotuzumab ozogamicin for all patients is 1.8 mg\/m2 per cycle, administered as three divided doses on day 1 (0.8 mg\/m2), day 8 (0.5 mg\/m2), and day 15 (0.5 mg\/m2). The recommended dosing for subsequent cycles depends on response to treatment. Details are available in the full prescribing information:\u00a0<a href=\"https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2017\/761040s000lbl.pdf\">https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2017\/761040s000lbl.pdf<\/a><\/p>\r\n\r\n\r\n\r\n<p>&nbsp;<\/p>\r\n\r\n\r\n\r\n<p>FDA previously granted Orphan Drug and Breakthrough Therapy designations to inotuzumab ozogamicin for the treatment of ALL, as well as priority review. A description of FDA expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics, available at:\u00a0<a href=\"https:\/\/www.fda.gov\/media\/86377\/download\">http:\/\/www.fda.gov\/downloads\/drugs\/guidancecomplianceregulatoryinformation\/guidances\/ucm358301.pdf<\/a>.<\/p>\r\n\r\n\r\n\r\n<p>&nbsp;<\/p>\r\n\r\n\r\n\r\n<p>Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA\u2019s MedWatch Reporting System by completing a form online at\u00a0<a href=\"http:\/\/www.fda.gov\/medwatch\/report.htm\">http:\/\/www.fda.gov\/medwatch\/report.htm<\/a>, by faxing (1-800-FDA-0178) or mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).<\/p>\r\n\r\n\r\n\r\n<p>&nbsp;<\/p>\r\n\r\n\r\n\r\n<p>Follow the Oncology Center of Excellence on Twitter\u00a0<a href=\"https:\/\/twitter.com\/@FDAOncology\" target=\"_blank\" rel=\"noreferrer noopener\">@FDAOncology.<\/a><a href=\"http:\/\/www.fda.gov\/about-fda\/website-policies\/website-disclaimer\">External Link Disclaimer<\/a><\/p>\r\n\r\n\r\n\r\n<p>&nbsp;<\/p>\r\n\r\n\r\n\r\n<p>Check out recent approvals at the OCE\u2019s new podcast, Drug Information Soundcast in Clinical Oncology (D.I.S.C.O.), available at\u00a0<a href=\"http:\/\/www.fda.gov\/DISCO\">www.fda.gov\/DISCO<\/a>.<br \/>\u00a0<\/p>\r\n","protected":false},"excerpt":{"rendered":"<p>On Aug. 17, 2017, the U.S. Food and Drug Administration approved inotuzumab ozogamicin (BESPONSA, Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). &nbsp; The approval was based on data from&#8230;<\/p>\n","protected":false},"author":8,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[103],"tags":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.3 - 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