BLINCYTO (blinatumomab) is a bispecific CD19-directed CD3 T-cell engager that binds to CD19 (expressed on cells of B-lineage origin) and CD3 (expressed on T cells).
|
PARAMETER |
DATA |
|
Manufacturer |
Amgen, Inc. |
|
Indication |
BLINCYTO is a bispecific CD19-directed CD3 T-cell engager indicated for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) |
|
Cell Substrate |
Chinese hamster ovary (CHO) cell line |
|
Manufacturing platform |
The description of the active substance manufacturing process and process controls/tests is appropriately detailed and starts with the expansion (into flasks, roller bottles and bag bioreactors) of 1 vial of working cell bank (WCB) of the Chinese hamster ovary (CHO) cell line, which is used to inoculate the main fermenter. One vial of working cell bank leads to a single batch of active substance, without cycling or generation of sub-lots. The harvest is collected by centrifugation followed by filtration steps to remove cells and cellular debris. The purification process includes three chromatography steps, two concentration/diafiltration steps and two virus removal/inactivation steps. The active substance is filtered, dispensed and stored at 2-8°C. No reprocessing is claimed. |
|
Dose in vial/final container |
38.5 mcg blinatumomab per 4mL vial |
|
Dose to patient |
For patients at least 45 kg in weight: 9 mcg/day on Days 1–7 and at 28 mcg/day on Days 8–28. For subsequent cycles, administer BLINCYTO at 28 mcg/day on Days 1–28 |
CLINICAL TRIALS
|
NCT |
TRIAL PHASE |
NO OF PATIENTS ENROLLED |
TITLE |
COUNTRIES |
|
Pivotal study |
||||
|
NCT01466179 |
2 |
225 |
United States, France, Germany, Italy, Spain, United Kingdom |
|
|
Supporting studies – Efficacy and Safety |
||||
|
NCT01209286 |
2 |
36 |
Germany |
|
|
NCT01471782 |
1, 2 |
93 |
United States, Austria, Canada, France, Germany, Italy, Netherlands |
|
|
Supporting Studies - Safety |
||||
|
NCT00560794 |
2 |
21 |
Germany |
|
|
NCT01207388 |
2 |
116 |
Austria, Belgium, France, Germany, Italy, Netherlands, Poland, Romania, Russian Federation, Spain, United Kingdom |
|
|
NCT00274742 |
1 |
76 |
Safety Study of the Bispecific T-cell Engager Blinatumomab (MT103) in Patients With Relapsed NHL |
Germany |
|
NCT01741792 |
2 |
25 |
Germany |
|
POST APPROVAL MANUFACTURING CHANGES
|
DATE |
TYPE OF CHANGE |
DESCRIPTION |
LINK |
|
03/20/2020 |
Dosage and Administration |
Changes to the reconstitution and preparation procedures based on the results of the label comprehension validation study. |
|
US pre-IND |
June 16, 2006 |
|
US Approval |
December 3, 2014 |
|
EU Approval |
November 23, 2015 |
|
Health Canada Approval |
January 12, 2016 |
|
Japanese Ministry of Health, Labor and Welfare (MHLW) Approval |
September 24, 2018 |
|
TGA Approval |
September 30, 2019 |
This application did not require discussion at an ODAC meeting due to the fact that trial results were superior to other products for a similar disease indication and the risk/benefit was thought to be favorable.