Besponsa Approved for Acute Lymphoblastic Leukemia
August 17, 2017 – The U.S. FDA has approved Besponsa® (inotuzumab ozogamicin), manufactured by Pfizer, for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL), a type of bone marrow cancer with rapid progression. Approximately 6,000 patients are diagnosed with B-cell precursor ALL in the U.S. each year. These patients have limited options for treatment.
A CD-22-directed antibody drug conjugate, Besponsa works by helping to block the growth of cancerous cells. The drug is available in single-dose vials of 0.9mg lyophilized powder, and must be reconstituted and further diluted, then administered by intravenous (IV) infusion over the course of one hour. Recommended dosing for the first cycle is 0.8mg/m2 on Day 1, 0.5mg/m2 on Day 8, and 0.5mg/m2 on Day 15. Patient response to therapy determines the dosing for subsequent cycles.
Besponsa carries a black box warning for increased risk of severe liver damage, including blockage of veins in the liver (veno-occlusive disease), and an increased risk of death following hematopoietic stem cell transplant. Besponsa was launched on August 22, 2017.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.