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

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

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

Shots:
  • 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

Click here to read full press release/ article | Ref: Amgen | Image:  2Vote

Shiwani Sharma

Shiwani Sharma is a Senior Editor at PharmaShots. She has in-depth knowledge of lifesciences industry including pharma and biotech sectors. She also covers news in field of Digital Health, Medtech and regulatory approvals from the US FDA, EU, and other global regulatory bodies in the industry. Additionally, she also writes Whitepapers, analysis reports, blogs on pharma and biotech industry. She is graduate in Biotechnology. She can be contacted on shiwani@pharmashots.com

Related post