Drug Development

Pfizer’s CD22-targeted cancer drug inotuzumab wins an accelerated OK at FDA

Pfizer’s armed antibody inotuzumab ozogamicin — held up as a top oncology contender at the pharma giant — has just won an accelerated approval at the FDA for relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

Liz Barrett

The drug is the first to reach the market which 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, as witnessed by its rapid-fire approval for its checkpoint inhibitor avelumab, partnered with Merck KGaA, and a $14 billion buyout deal for Medivation.

Investigators tracked a complete response rate of 81% for this drug — which will now be sold as Besponsa — compared to 29% in a chemo arm. And that has some analysts projecting peak sales of around $2 billion, a solid hit for the pharma giant’s oncology division.

The approval — coming after the FDA offered a 6-month priority review schedule — marks a big comeback for Pfizer on this drug, which flopped in a Phase III trial for non-Hodgkin’s lymphoma four years ago,

Said Liz Barrett, global president, Pfizer Oncology:

“Besponsa will help address a significant need for new treatment options in B-cell acute lymphoblastic leukemia, and may help more patients reach stem cell transplant, which provides the best chance for long term remission. We’re proud to build on our continued commitment to patients with hematologic malignancies, and will continue our work to find new treatments in acute lymphoblastic leukemia and other blood cancers.”

Image: Shutterstock

The best place to read Endpoints News? In your inbox.

Comprehensive daily news report for those who discover, develop, and market drugs. Join 44,100+ biopharma pros who read Endpoints News by email every day.

Free Subscription

Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
Marketing Associate - Demand Generation
Catalytic Data Science Charleston, SC
Associate Principal, Life Sciences Partnerships
Flatiron Health New York City or San Francisco

Visit Endpoints Careers ->