FDA granted Fast Track Designation for 177Lu-PNT2002 for the treatment of mCRPC

CAR-T Digest - August 2020

April 24, 2023: 177Lu-PNT2002 (IV) / Prostate Cancer / Lantheus and POINT Biopharma: Granted fast track designation by US FDA

US FDA has granted fast track designation for 177Lu-PNT2002 for the treatment of mCRPC
- 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
Currently, a Phase 3 SPLASH trial is ongoing investigating 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; top-line data is expected in H2 2023
“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.” said Jean-Claude Provost, M.D., Chief Medical Officer at Lantheus