Health Canada issues safety warning on Amgen's Blincyto

There have been reported cases of life-threatening, sometimes fatal pancreatitis associated with the use of Blincyto (blinatumomab) in clinical trial and post-market settings. As a result, medicines regulatory Health Canada, in collaboration with the drug’s maker Amgen (Nasdaq: AMGN), has issued a safety warning and has updated the Canadian Product Monograph (CPM) for Blincyto.

Blincyto, which was approved for marketing in the USA in 20154 and in 2015 in Europe, is indicated for the treatment of adults with Philadelphia chromosome-negative relapsed or refractory B precursor acute lymphoblastic leukemia (ALL).

In clinical trials, six cases suggestive of pancreatitis were reported in patients receiving Blincyto. Of these, one case of pancreatitis was serious.  It occurred in a patient who had elevations of lipase and total bilirubin before starting treatment with Blincyto; the pancreatitis did not resolve with the discontinuation of Blincyto. Two remaining cases described increases in pancreatic enzymes (such as increased lipase) with associated symptoms. The three other remaining cases were reported as non-serious pancreatitis.