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Lantheus and POINT Biopharma announced that the FDA has granted Fast Track designation for 177Lu-PNT2002, a treatment for metastatic castration resistant prostate cancer (mCRPC). This designation aims to facilitate the drug's development and review process due to the significant unmet medical need in this area. The therapy combines a PSMA-targeted ligand with a beta-emitting radioisotope. Both companies emphasized the importance of this milestone, with Lantheus expressing optimism about working closely with the FDA to advance the therapy. The ongoing Phase 3 SPLASH trial, which assesses the efficacy of 177Lu-PNT2002, has completed enrollment, with top-line results expected in the second half of 2023. Lantheus holds exclusive worldwide commercialization rights for this product.