How George Tidmarsh crossed the FDA-industry Rubicon

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To say that it has been an eventful few months for George Tidmarsh would be a bit of an understatement.

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Mikkael A. Sekeres, MD, MS
Chief, Division of Hematology, Professor of medicine, Sylvester Comprehensive Cancer Center, University of Miami; Author, “Drugs and the FDA: Safety, Efficacy, and the Public’s Trust”
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Last week, FDA granted accelerated approval to Replimune Group Inc. for it’s biologic, RP1 (vusolimogene oderparepvec), following the FDA Cellular, Tissue, and Gene Therapies Advisory Committee’s 10:3 vote in support of the biologic in combination with nivolumab for the treatment of advanced melanoma in patients who have progressed on prior anti-PD-1 therapy.
FDA has granted an accelerated approval to RP1 (vusolimogene oderparepvec) following the agency’s Cellular, Tissue, and Gene Therapies Advisory Committee’s 10:3 vote in support of the biologic in combination with nivolumab for the treatment of advanced melanoma in patients who have progressed on prior anti-PD-1 therapy.
FDA approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan) in combination with an androgen receptor pathway inhibitor for patients with prostate-specific membrane antigen-positive metastatic androgen pathway modulation-naive/sensitive prostate cancer, commonly known as metastatic hormone-sensitive prostate cancer.
Mikkael A. Sekeres, MD, MS
Chief, Division of Hematology, Professor of medicine, Sylvester Comprehensive Cancer Center, University of Miami; Author, “Drugs and the FDA: Safety, Efficacy, and the Public’s Trust”

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