Lantheus and Point Biopharma Prostate Cancer Candidate Gets Fast Track Status

The FDA has granted Fast Track designation to Lantheus and Point Biopharma’s 177Lu-PNT2002 for the treatment of metastatic castration-resistant prostate cancer.

The drug candidate is an investigational radiopharmaceutical that targets prostate-specific membrane antigen, a protein found on normal prostate cells, but found in higher concentrations on prostate cancer cells.

117Lu-PNT2002 is currently under a phase 3 clinical trial setting, with enrollment complete and top-line data expected in the second half of this year.

The FDA’s Fast Track process facilitates the development and expedites the review of drugs to treat serious conditions and fill unmet medical needs.

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