3:48 PM
Feb 14, 2018
 |  BC Extra  |  Company News

March 7 ODAC meeting for Amgen's Blincyto

Amgen Inc. (NASDAQ:AMGN) said FDA’s Oncologic Drugs Advisory Committee will meet on March 7 to discuss an sBLA for Blincyto blinatumomab to treat minimal residual disease (MRD)-positive B cell precursor acute lymphoblastic leukemia (ALL). The sBLA is under Priority Review and has a March 29 PDUFA date.

Last year, FDA granted Blincyto full approval to treat relapsed or refractory B cell precursor ALL, including Philadelphia chromosome-positive (Ph+) relapsed or refractory B cell precursor ALL. It has had accelerated approval to treat Ph- relapsed or refractory B cell precursor ALL since 2014 (see BioCentury Extra, July 12, 2017).

Blincyto is a bispecific T cell engager (BiTE) against CD19.

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