Zacks’ Voice of the People Highlights user MackTheKnife: “DNDN Presents Data on Provenge MOA” from the People & Picks community.
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DNDN Presents Data on Provenge MOA
IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment) clinical-trial data showing evidence of immune responses in patients treated with Provenge and supporting its proposed mechanism of action were presented by the Dendreon Corp. (DNDN) at the American Association for Cancer Research’s 101st Annual Meeting, which began Saturday and ends today in Washington.
The U.S. Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) date of May 1 to Dendreon’s amended biologics license application for Provenge, which the company is seeking to have licensed for men with metastatic castrate-resistant prostate cancer (CRPC). Should the FDA follow the data this time around, Provenge would be the first product in the new therapeutic class known as active cellular immunotherapies.
In a press release today, David Urdal, senior vice president and chief scientific officer of Dendreon, notes: “These data strongly support our understanding of the proposed mechanism of action of active cellular immunotherapies. There is clear evidence that Provenge primes the T-cell component of the immune system in vivo through ex vivo activation, generating a successful and long-lasting immune response.”
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