A European regulatory setback for a Bristol-Myers Squibb (BMY) blood-cancer drug could have a negative spillover effect for Agios Pharmaceuticals (AGIO) and its sole wholly owned drug.
On Friday, the European Medicines Agency disclosed that Bristol withdrew a marketing application for Idhifa, a targeted medicine to treat acute myeloid leukemia, after an ongoing review had concluded that the drug’s clinical data did not support approval.
Idhifa was developed initially by Agios and then licensed to Celgene, since acquired by Bristol. The Food and Drug Administration approved Idhifa in August 2017 to treat patients with a specific mutation called IDH2. The FDA approval was based on a single-arm clinical trial of 200 patients with AML that was no longer responsive to other therapies.