FDA

Pfizer’s data mining hits pay dirt as FDA panel backs a comeback for Mylotarg

Seven years ago, Mylotarg was an embarrassment for Pfizer and the FDA. Regulators forced it off the market in 2010, right after Pfizer’s big Wyeth buyout and 10 years after it was given the agency’s first accelerated approval. The drug failed a confirmatory study years after it hit the market, and the FDA yanked it.

Today, though, the drug made a big step back toward the market. An FDA advisory committee voted 6 to 1 to endorse the drug when added to chemotherapy for patients with newly-diagnosed CD33-positive acute myeloid leukemia.

All that data that had been accumulated on this drug over the years ultimately proved to be the resource needed to mount a comeback. Pfizer’s BLA included data from the original NDA, along with a late-stage open label study and meta-analysis involving thousands of patients over a decade of clinical investigation.

“Clinical studies investigating Mylotarg have provided a significant body of evidence supporting the risk:benefit profile of Mylotarg in AML,” said Jorge Cortes of the MD Anderson Cancer Center. “Based on the totality of the efficacy and safety data, Mylotarg, if approved, has the potential to be an important treatment option for adult patients with AML.”


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