1:10 PM
Mar 07, 2018
 |  BC Extra  |  Company News

FDA panel backs Blincyto in ALL subpopulation

FDA’s Oncologic Drugs Advisory Committee voted 8-4 that data from a Phase II trial showed the benefits of Blincyto blinatumomab from Amgen Inc. (NASDAQ:AMGN) outweigh its risks in treating minimal residual disease (MRD)-positive B cell precursor acute lymphoblastic leukemia. An sBLA for Blincyto is under Priority Review in the indication, with a PDUFA date of March 29.

The committee discussed the results of the pivotal Phase II BLAST trial in patients with ALL in complete remission who have MRD of at least 0.1%. Amgen reported in 2014 that Blincyto met the trial’s primary endpoint, which measured MRD response rate (see BioCentury Extra, Dec. 8, 2014).

Last year, FDA granted Blincyto full approval for relapsed or refractory B cell precursor ALL. The bispecific T cell engager (BiTE) against CD19 had accelerated approval since 2014 to treat Philadelphia chromosome-negative (Ph-) relapsed or refractory B cell precursor ALL (see BioCentury Extra, July 12, 2017).

Amgen was up $0.20 to $114.76 on Wednesday.

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