publication date: Jul. 14, 2017

Removed from U.S. market in 2011, Pfizer’s Mylotarg slated to return following results of a French study that tested a new regimen

By Paul Goldberg

The FDA Oncologic Drugs Advisory Committee July 11 voted to approve Pfizer’s Mylotarg (gemtuzumab ozogamicin, GO), a CD33-directed antibody-drug conjugate for the indication of “combination therapy with daunorubicin and cytarabine for the treatment of adult patients with previously untreated, de novo CD33-positive acute myeloid leukemia.

The committee voted 6-1 in favor of approval.

The vote will almost certainly lead to Mylotarg’s return to market with a full approval, at a lower dose and as an add-on to a standard treatment regimen.

Consider the timeline:

In May 2000, Mylotarg received an accelerated approval as a single agent for relapsed AML patients who are over 60 and who are not candidates for cytotoxic chemotherapy.

A confirmatory study conducted by SWOG (S0106) showed no improvement in CR, DFS or OS with the addition of Mylotarg. There was also a higher rate of fatal toxicities in the induction phase on the Mylotarg arm.

The confirmatory trial wasn’t in the same setting and used Mylotarg as part of a combination regimen, but then again confirmatory trials often seek to broaden indications. FDA concluded that the benefit was not confirmed and there was potentially a decrease in safety. As a result, the sponsor pulled the drug from the U.S. market in November 2011.

However, studies of Mylotarg continued, with some showing benefit in the front-line setting. As a result, demand for it on compassionate basis continued to increase over the years. The therapy was brought back to FDA thanks to an investigator-initiated French trial, ALFA-0701, which tested a different dosing schedule in de novo disease.

Mylotarg was approved at 9 mg/m2. SWOG tested it in a 6mg/m2 … Continue reading Removed from U.S. market in 2011, Pfizer’s Mylotarg slated to return following results of a French study that tested a new regimen

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