Blincyto Approved for Children
August 30, 2016 – The US FDA approved Amgen’s supplemental biologics license application (sBLA) for Blincyto® (blinatumomab). Blincyto is a bispecific CD19-directed CD3 T-cell engager that was first FDA approved in 2014 for treating adults who have Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (ALL) that has recurred or that is no longer responding to previous treatment. FDA now has approved it for children and teens with the same type of relapsed or refractory ALL. It is dosed by weight for patients who weigh at least 45kg (99 pounds), and by body surface area (BSA) for patients who weigh less. Blincyto is given on 42-day cycles infused through a continuous intravenous (IV) pump for 28 days, which is followed by 14 days with no drug. Patients should be treated in a healthcare facility for the first nine days of their first treatment cycles, and for the first two days of cycle two. Up to five cycles may be needed for a course of treatment. Labeling for Blincyto carries boxed warnings about potentially fatal neurological toxicity and cytokine release syndrome that it could cause. Additionally, its use may be associated with a number of other possibly severe side effects including infections, neutropenia, pancreatitis and tumor lysis syndrome.
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 regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular 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
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.