Pharma Focus Asia

Lantheus and POINT Biopharma Announce Fast Track Designation Grant by FDA for ¹⁷⁷Lu-PNT2002

Tuesday, April 25, 2023

Lantheus Holdings, Inc. and POINT Biopharma Global, Inc. has granted Fast Track designation for 177Lu-PNT2002 for the treatment of metastatic castration resistant prostate cancer (mCRPC).

Fast track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and address unmet medical needs. PNT2002 is an innovative PSMA-targeted 177Lu-based radiopharmaceutical therapy that combines a PSMA-targeted ligand, PSMA-I&T, with the beta-emitting radioisotope no-carrier-added 177Lu.

The Phase 3 SPLASH trial is a multi-center, randomized, open label assessment of 177Lu-PNT2002 in participants with PSMA-expressing mCRPC who have progressed on androgen receptor pathway inhibitor therapy and refuse, or are not eligible for, chemotherapy. Participants were randomized 2:1 with those in arm A receiving 177Lu-PNT2002 and those in arm B receiving either abiraterone or enzalutamide. Participants in arm B who experience centrally assessed radiographic progression and meet protocol eligibility have the option to crossover and receive 177Lu-PNT2002. Patients are subject to follow-up for up to 5 years from their first 177Lu-PNT2002 dose. The primary endpoint of the study is radiographic progression-free survival. Key secondary endpoints include overall survival, overall response rate, and duration of response. Safety and tolerability will also be assessed. Enrollment in the trial is complete and SPLASH top line data is expected in the second half of 2023.

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