Did the FDA drop the ball on Mylotarg?

Pfizer's (NYSE: PFE) withdrawal of Mylotarg from the U.S. market is raising questions about the FDA and its accelerated-approvals program. The questions come in light of clinical research showing that the decade-old drug not only doesn't help patients, but might actually harm them.

The FDA allows some drugs for serious diseases to win approval quickly based on preliminary data rather than full-on, large clinical trials. These meds then have to undergo further testing to stay on the market. Wyeth won the nod for Mylotarg in 2000. Pfizer acquired the drug, which has been linked to liver and lung complications, when it bought Wyeth last year.

So, here are the questions: Why did it take a full decade to get this data? Why did the FDA allow Wyeth to wait four years after accelerated approval to launch the post-marketing study? And why did it take an entire year after the Mylotarg study was stopped--because of the drug's lack of efficacy and its potential risks--for FDA to effect a withdrawal?

Even FDA officials appear to be chastened. Robert Kane, acting deputy director for safety in the FDA's hematology division, tells Bloomberg that the four-year delay in beginning a required follow-up study shows that the accelerated approval process needs more oversight. "Accelerated approval still has a place in the approval process but it's also more important that we learn over the years that the whole development plan be set up well in advance," Kane tells the news service. He adds that trials should be planned and, if possible, under way when the sponsor submits its application to the agency.

FDA says Mylotarg is the first med approved under the accelerated process to be withdrawn, and the drug is under study in other clinical trials, which will continue. If those studies come up positive, then Pfizer could conceivably apply again for FDA approval.

- get the Pfizer press release
- read the FDA's release
- see the coverage at Bloomberg
- find the post at Pharmalot
- read the article from Stanford Medical School's Scope
- see the news from Reuters
- check out the Wall Street Journal story

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