FDA Grants Fast Track Designation to New Prostate Cancer Treatment

The FDA will speed up its review of ¹⁷⁷Lu-PNT2002 for certain patients with prostate cancer.

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to 177Lu-PNT2002 metastatic, castration-resistant prostate cancer (mCRPC), according to a press release by the companies behind the treatment.

The Fast Track process is intended to encourage development and expedite review of drugs treating serious conditions and addressing unmet medical needs, the statement from Lantheus Holdings and POINT Biopharma Global explained.

“Fast track designation by the FDA is an important milestone and recognizes the potential for Lu-PNT2002 to address the significant unmet need for mCRPC patients,” Dr. Jean-Claude Provost, chief medical officer for Lantheus, said in Monday’s announcement. “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 Lu-PNT2002, with the potential to make a meaningful difference for patients who require new treatment options.”

The treatment is currently being studied in the phase 3 SPLASH trial, analyzing how well Lu-PNT2002 delays progression among patients with prostate cancer versus Zytiga (abiraterone) or Xtandi (enzalutamide).

The approximately 415 SPLASH trial participants are patients with prostate-specific membrane antigen (PSMA)-expressing mCRPC who have progressed on androgen receptor pathway inhibitor therapy and have either refused or are ineligible for chemotherapy.

SPLASH is primarily analyzing radiographic, progression-free survival (the time from the start of treatment to disease progression or death of any cause). Researchers will also evaluate the proportion of patients whose disease shrinks or disappears from treatment, duration of response, time from treatment until death of any cause (overall survival), PSA response and biochemical progression-free survival, which is the time from trial enrollment to the date of the first time their PSA increases more than 25%.

Enrollment in the study is complete and initial data is expected in the second half of this year, according to the announcement.

Lu-PNT2002 is a PSMA-targeted, Lu-based radiopharmaceutical therapy combining the PSMA-targeted ligand PSMA-I&T with the beta-emitting radioisotope no-carrier-added Lu, according to the release. Radioligand treatment involves small doses of radiation delivered directly to cancerous cells, largely sparing healthy cells.

“The FDA Fast Track designation for Lu-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, chief medical officer for POINT Biopharma, said in the press release. “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 Lu-PNT2002 to patients as quickly as possible.”

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