The FDA granted Lantheus Holdings (NASDAQ:LNTH) and POINT Biopharma (NASDAQ:PNT) fast track designation for 177Lu-PNT2002 for the treatment of metastatic castration resistant prostate cancer (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.
Lantheus in-licensed exclusive worldwide commercialization rights, excluding certain Asian territories to 177Lu-PNT2002 from POINT in December 2022.
“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,” Neil Fleshner, M.D. and CMO of POINT, said in a statement.
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.
Enrollment in the trial is complete and SPLASH top line data are expected in the second half of 2023.
