UPDATED: Pfizer hits the brakes on their pivotal trial for a BCMA/CD3 bispecific on safety concerns while FDA roadblock is holding up Duchenne MD PhIII
Pfizer’s ambitious plan to take a Phase II study of its BCMA CD3-targeted bispecific antibody elranatamab (PF-06863135) and run it through to an accelerated approval has derailed.
The pharma giant said in a release this morning that they have halted enrollment for their MagnetisMM-3 study after researchers tracked three cases of peripheral neuropathy in the ongoing Phase I. They are now sharing info with the FDA as they explore the red safety flag.
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