Pfizer Pulls Mylotarg For Safety 10 Years After Accelerated Approval
Although Pfizer's voluntary withdrawal of its acute myeloid leukemia therapy Mylotarg is the first complete withdrawal of an accelerated approval NDA, but as in other cases where the confirmatory trial fails to substantiate the initial signs of efficacy that supported the accelerated approval, FDA is not completely closing the door on access to the drug
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Taking on critics who say it is too quick to award accelerated approval based on surrogate endpoints and limited safety data, agency's 25-year review shows cancer drugs receiving accelerated approval generally have twice the amount of safety data as efficacy, and more than half have confirmed clinical benefit after approval.
Return to market for leukemia drug expected to generate another orphan drug exclusivity from new indication; Mylotarg also appears on track for 12-year biologics exclusivity after being approved as BLA, rather than an NDA as it was for its initial 2000 approval.
Keeping Track: US FDA's Late Summer Approval Extravaganza Stars Three Novel Agents, Features Return Of Mylotarg
Kymriah, Vabomere, and benzidazole approvals joined by new indications for Austedo, Faslodex.