Pfizer shortens comeback campaign for armed antibody inotuzumab, lands quick FDA review
Pfizer’s armed antibody inotuzumab ozogamicin — held up as a top oncology contender at the pharma giant — is being given the red carpet treatment at the FDA. Pfizer said this morning that regulators agreed to provide a priority review for the drug as a new treatment for relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
The news marks the latest comeback advance for the antibody-drug conjugate, which flopped in a Phase III trial for non-Hodgkin’s lymphoma four years ago, badly tarnishing the prospects for a drug that had been touted as a top contender by CEO Ian Read. In the fall of 2015, though, regulators handed the company a breakthrough therapy designation for inotuzumab, a few months after Pfizer scored positive late-stage data in ALL.
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