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Amgen's BLINCYTO (blinatumomab- BiTE) Receives EU Expanded approval for pediatric 2L+ B-cell-ALL

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Amgen's BLINCYTO (blinatumomab- BiTE) Receives EU Expanded approval for pediatric 2L+ B-cell-ALL

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  • This approval is based on P-I/II ‘205 study for the treatment of pediatric patients aged 1-17yr with Philadelphia chromosome-neg CD19 +ve (r/r) B-cell precursor ALL
  • P-I/II ‘205 study (N=93) administering dose (5 -15 μg/m2/day on days 1-7 day- 8-28 for cycle 1- followed by two weeks off- and 15 μg/m2/day on days 1-28 two weeks off for subsequent cycles
  •  Results: median Age is eight yrs. (range: 7mos to 17yrs); CR/CR+partial hematologic recovery (n=20/70-28.6%); (17/20- 85%) occurring within the first cycle

/ article | Ref: Amgen | Image:  2Vote

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