Article
FDA Fast Track of Novel Drug May Open Doors for Certain Patients with Non-Small Cell Lung Cancer
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The FDA’s fast track designation to poziotinib for use in previously treated patients with non-small cell lung cancer whose disease harbors a certain genetic mutation, may open the doors to an accelerated approval.
The Food and Drug Administration (FDA) has granted a fast track designation to poziotinib for use in previously treated patients with non-small cell lung cancer whose disease harbors HER2 exon 20 mutations, according to the agent’s manufacturer, Spectrum Pharmaceuticals.
“There are currently no approved therapies to treat patients with HER2 exon 20 mutations, and we are pleased that the FDA has granted fast track designation for poziotinib,” said Spectrum Pharmaceuticals president and CEO Joe Turgeon in a news release. “Momentum is building to unlock the potential of poziotinib.”
The agency grants fast track designation “to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need,” according to its website. This designation has the potential to lead to an accelerated approval for a drug.
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