FDA Grants Fast Track Status to Lantheus and POINT Biopharma’s Promising Prostate Cancer Treatment 177Lu-PNT2002

Lantheus Holdings, Inc. and POINT Biopharma Global, Inc. have been granted a Fast Track designation by the U.S. Food and Drug Administration for their innovative radiopharmaceutical therapy 177Lu-PNT2002—a PSMA-targeted 177Lu-based therapy combining a PSMA-targeted ligand, PSMA-I&T, with the beta-emitting radioisotope no-carrier-added 177Lu—for the treatment of metastatic castration resistant prostate cancer (mCRPC). This Fast Track designation is designed to facilitate the development and expedite the review of drugs that treat serious conditions and address unmet medical needs.

Lantheus is thrilled to announce that the FDA has granted Fast Track designation to their product 177Lu-PNT2002, which has the potential to provide a much-needed treatment option to men with metastatic castrate-resistant prostate cancer (mCRPC).

With this designation, Lantheus and their partner POINT can work closely with the FDA to expedite the development and approval process of this promising therapy. The potential of 177Lu-PNT2002 to make a meaningful difference for patients is a cause for excitement and optimism.

“At POINT Biopharma, we are thrilled to have received the FDA Fast Track designation for 177Lu-PNT2002 for the treatment of metastatic Castration-resistant Prostate Cancer (mCRPC). With our continued focus on supply chain excellence, we believe that we are well-positioned to meet market demands post-approval and bring 177Lu-PNT2002 to patients as quickly as possible.

Radioligand therapy is quickly becoming a key pillar of cancer treatment, and we are proud to be part of the effort to provide a meaningful therapeutic option to patients in need.”

The SPLASH trial is a groundbreaking clinical study with the goal of evaluating the efficacy of 177Lu-PNT2002 as a treatment for men with metastatic castration-resistant prostate cancer (mCRPC) who have failed or are ineligible for chemotherapy.

The trial is a multi-center, randomized, open label study with 177Lu-PNT2002 being administered to participants in arm A and either abiraterone or enzalutamide being administered to participants in arm B. Participants in arm B who experience radiographic progression and meet protocol eligibility have the option to crossover and receive 177Lu-PNT2002.

The primary endpoint of the trial is radiographic progression-free survival and the results are expected in the second half of 2023. The study will also assess overall survival, overall response rate, duration of response, and safety and tolerability, providing important insight into the efficacy of 177Lu-PNT2002 in treating mCRPC.

About Lantheus

At Lantheus, we have been helping to change lives for more than 65 years, working to make patient outcomes better through advanced diagnostics, radiotherapeutics and artificial intelligence solutions that help clinicians find, fight and follow disease. With offices in Massachusetts, New Jersey, Canada and Sweden, we are passionate about making a difference and improving lives.

About POINT Biopharma Global Inc.

POINT Biopharma Global Inc. is at the forefront of the fight against cancer with a portfolio of targeted radioligands, a seasoned management team, an industry-leading pipeline, in-house manufacturing capabilities and secured supply for medical isotopes.

Its active clinical trials, such as FRONTIER and SPLASH, are revolutionizing precision medicine by focusing on pan-cancer programs and treatments for people with metastatic castration resistant prostate cancer after second-line hormonal treatment. With POINT, the future of cancer treatment is brighter than ever.

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