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# Regulatory Review Period Determined for Blincyto
- URL: https://www.fdaweb.com/regulatory-review-period-determined-for-blincyto/
- Published: 2018-02-06T12:00:00.000Z
- Updated: 2026-09-14T23:20:25.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5140688

*Federal Register* notice: FDA has determined for patent extension purposes that the regulatory review period for Amgen’s Blincyto (blinatumomab) is 2,850days. Of this time, 2,774 days occurred during the testing phase and 76 days during the approval phase. Blincyto is indicated for treating Philadelphia chromosome-negative relapsed or refractory B-cell precuror acute lymphoblastic leukemia. To view the notice, click [here](https://s3.amazonaws.com/public-inspection.federalregister.gov/2018-02419.pdf?ref=fdaweb.com).