Amgen gets EU conditional marketing approval for Blincyto to treat ALL

US biotech company Amgen (Nasdaq: AMGN) on Tuesday said the European Commission has granted conditional marketing authorization for its Blincyto (blinatumomab) to treat Philadelphia chromosome-negative (Ph-) relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL).

Sean Harper, executive vice president of R&D at Amgen, said: “Blincyto has demonstrated efficacy in treating relapsed or refractory ALL, a very difficult-to-treat disease for which historically patients had limited therapeutic options. This approval represents an important milestone in immunotherapy research. Blincyto is the first clinical validation of the BiTE platform, a new and innovative approach that helps the body’s own immune system fight cancer.”

Approval from the EC grants a centralized conditional marketing authorization with unified labeling in the 28 countries that are members of the EU. Norway, Iceland and Liechtenstein, as members of the European Economic Area (EEA), will take corresponding decisions on the basis of the decision of the EC. Conditional license requires the license to be renewed every year and it will be converted to full standard license once post-licensing commitments have been fulfilled.