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# ODAC Sees Value in Withdrawn Pfizer Drug
- URL: https://www.fdaweb.com/odac-sees-value-in-withdrawn-pfizer-drug/
- Published: 2017-07-12T12:00:00.000Z
- Updated: 2026-09-14T22:33:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139115

The Oncologic Drugs Advisory Committee voted 6-1 on 7/11 to recommend to FDA that Pfizer’s Mylotarg (gemtuzumab ozogamicin) 3 mg/m2 in combination with chemotherapy has a favorable risk/benefit profile for patients with newly-diagnosed CD33-positive acute myeloid leukemia (AML). Mylotarg was originally approved under FDA’s accelerated approval program in 2000 for use as a single agent in patients with CD33-positive AML who had experienced their first relapse and were age 60 or older. The drug was voluntarily withdrawn by Pfizer in 2010 after a confirmatory Phase 3 trial did not show a clinical benefit for its use as a single agent in patients with CD33-positive AML, and the rate of fatalities as a result of treatment-related toxicity was significantly higher in the Mylotarg arm of the trial.

Committee discussions were based on a BLA currently under agency review. Pfizer says it is seeking approval for two U.S. indications: in combination with standard chemotherapy for treating previously untreated *de novo* CD33-positive AML, and as monotherapy for treating CD33-positive AML patients in first relapse who are age 60 or older and who are not considered candidates for other cytotoxic chemotherapy.

Mylotarg is described as an investigational antibody-drug conjugate comprising the cytotoxic agent calicheamicin, attached to a monoclonal antibody targeting CD33, an antigen expressed on the surface of myeloblasts in more than 90% of AML patients. Pfizer says that when Mylotarg binds to the CD33 antigen on the cell surface, it is absorbed into the cell and calicheamicin is released, causing cell death.