Lantheus and POINT Biopharma Announce FDA Grants Fast Track Designation for ¹⁷⁷Lu-PNT2002 for the Treatment of Metastatic Castration Resistant Prostate Cancer

Lantheus Holdings, Inc. and POINT Biopharma Global, Inc. announced the U.S. Food and Drug Administration (FDA) 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.

“Fast track designation by the FDA is an important milestone and recognizes the potential for ¹⁷⁷Lu-PNT2002 to address the significant unmet need for mCRPC patients,” said Jean-Claude Provost, M.D., Chief Medical Officer at Lantheus. “We are encouraged by the FDA’s decision as it reflects the need for FDA approved and widely available treatments for these patients. This designation will allow us to work closely with the FDA, along with our partner POINT, to quickly advance ¹⁷⁷Lu-PNT2002, with the potential to make a meaningful difference for patients who require new treatment options.”

“The FDA Fast Track designation for ¹⁷⁷Lu-PNT2002 underscores its potential to address a serious unmet need and serve as a meaningful therapeutic option for patients with mCRPC,” said Dr. Neil Fleshner, M.D., Chief Medical Officer of POINT Biopharma. “We are seeing that radioligand therapy is quickly becoming another pillar of cancer treatment, and, with our continued focus on supply chain excellence, we believe that we are very well positioned to meet market demands post approval. We will continue to work closely with our partner Lantheus and with the FDA to bring ¹⁷⁷Lu-PNT2002 to patients as quickly as possible.”

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.

Lantheus in-licensed exclusive worldwide commercialization rights (excluding certain Asian territories) to ¹⁷⁷Lu-PNT2002 from POINT in December of 2022.