> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Amgen Gains Expanded Approval for Blincyto
- URL: https://www.fdaweb.com/amgen-gains-expanded-approval-for-blincyto/
- Published: 2018-03-29T12:00:00.000Z
- Updated: 2026-09-14T23:56:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141101

FDA has granted Amgen accelerated approval for Blincyto (blinatumomab) and its expanded use to treat adults and children with B-cell precursor acute lymphoblastic leukemia (ALL) who are in remission but still have minimal residual disease (MRD). “Because patients who have MRD are more likely to relapse, having a treatment option that eliminates even very low amounts of residual leukemia cells may help keep the cancer in remission longer,” FDA Oncology Center of Excellence director **Richard Pazdur** is quoted in a [release](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm603151.htm?ref=fdaweb.com) as saying. “We look forward to furthering our understanding about the reduction in MRD after treatment with Blincyto. Studies are being conducted to assess how Blincyto affects long-term survival outcomes in patients with MRD.”

Blincyto works by attaching to CD19 protein on the leukemia cells and CD3 protein found on certain immune system cells. “Bringing the immune cell close to the leukemia cell allows the immune cells to attack the leukemia cells better,” the release says. FDA originally approved Blincyto under accelerated approval 12/2014 for treating Philadelphia chromosome-negative relapsed or refractory positive B-cell precursor ALL. Full approval for this indication was granted 7/2017.