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.
A priority review slashes four months off the process, giving Pfizer an August PDUFA date. The EMA also has this drug under review.
The drug is designed to bind to the CD22 antigen on B-cells, where it then goes into the cancer cell to deliver a cytotoxic payload of calicheamicin, destroying the cell. Pfizer has made a strong push on the cancer front in recent years, and is also angling for an approval of a checkpoint inhibitor partnered with Merck KGaA.
“ALL that has recurred after, or is refractory to, first-line therapy is a rapidly progressing and deadly disease,” said Mace Rothenberg, MD, chief development officer, Oncology, Pfizer Global Product Development. “Based on the positive results of the INO-VATE 1022 Phase 3 trial, we believe inotuzumab ozogamicin, if approved, represents a new treatment option for adult patients with relapsed or refractory B-cell precursor ALL.”
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