Fulcrum Therapeutics said it is discontinuing development of pociredir, its experimental oral treatment for sickle cell disease (SCD), after the U.S. Food and Drug Administration (FDA) raised concerns that the therapy may increase the risk of certain blood cancers.
The concerns stem from the unexpectedly high rate of secondary blood cancers observed with Tazverik (tazemetostat), a cancer therapy that targets the same protein complex as pociredir, which led to the therapy’s withdrawal from all markets earlier this year.
Although the two drugs act on different parts of that protein complex and clinical trials have supported pociredir’s therapeutic potential in people with SCD, the FDA “left no viable regulatory path forward for further clinical development of pociredir,” Fulcrum said in a company press release.