EMA Approves Blincyto, with Conditions

September 28, 2015
BioPharm International Editors

Although the Committee for Medicinal Products for Human Use (CHMP) gave Blincyto a positive opinion, full approval of the drug in the EMA will rely on additional clinical studies.

On Sept. 25, 2015, Blincyto received conditional marketing authorization in Europe for the treatment of adults with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL). The approval is conditional because there is a lack of complete clinical trial data; according to an Amgen press release announcing the positive opinion about the drug, “continued approval for this indication may be contingent upon verification of clinical benefit in subsequent trials."

FDA approved Blincyto (blinatumumab) in December 2014 under FDA’s Accelerated Approval program. Blincyto is the only bispecific CD19-directed CD3 T-cell engager (BiTE) drug approved by FDA. It works by targeting cell-surface proteins CD19 and CD3 simultaneously bringing T cells to targeted cancer cells via dual targets.

In September 2015, Amgen announced it will pay $45 million to license Xencor’s XmAb bispecific technology platform for the development of a total of six targets. The company plans to use a T-cell engaging bispecific antibody directed against CD38 to complement its existing BiTE platform.

Source: Reuters, Amgen