FDA approved Posluma (flotufolastat F 18), an optimized, high-affinity radiohybrid Prostate-Specific Membrane Antigen-targeted PET imaging agent. Posluma is indicated for positron emission tomography of prostate-specific membrane antigen-positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or with suspected recurrence based on elevated serum prostate-specific antigen level.
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.
