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Endocyte Announces FDA Acceptance of Radiographic Progression Free Survival (rPFS) as an Alternative Primary Endpoint of the VISION Trial in Addition to Overall Survival (OS)

(Morningstar) Sept 10, 2018 - Endocyte, Inc., a biopharmaceutical company developing targeted therapeutics for personalized cancer treatment, today announced that following a meeting with the U.S. Food and Drug Administration (FDA), it was determined that rPFS is an appropriate efficacy endpoint in the ongoing phase 3 VISION trial to support the submission of a New Drug Application (NDA) for full FDA approval of 177Lu-PSMA-617 for the treatment of metastatic castration-resistant prostate cancer (mCRPC).

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Tomasz M. Beer, MD, FACP (Posted: September 10, 2018)

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Intermediate endpoints can speed the delivery of impactful drugs to patients and in prostate cancer, where we now have multiple lines of therapy, it is important that we consider intermediate endpoints because overall survival can be impacted by subsequent therapies and take a long time to measure. But the progression-free survival advantage has to be clear and compelling in quality and magnitude to serve as a robust measure of patient benefit.

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Tomasz M. Beer, MD, FACP

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