Also known as: Lu-177 PSMA
Lutetium Lu 177 vipivotide tetraxetan is a PSMA-targeted radioligand therapy marketed as Pluvicto for metastatic castration-resistant prostate cancer. It is used in PSMA-positive disease settings after androgen receptor pathway inhibitor therapy and in specific pre/post-taxane contexts. The FDA first approved this product in March 2022, with later expansion for earlier use.
Novartis reported Phase III PSMAddition data showing Pluvicto plus standard of care cut the risk of PSA progression by 58% in PSMA-positive metastatic hormone-sensitive prostate cancer. Regulatory decisions in the United States, China and Japan are expected in the second half of 2026.
ORIC selected rinzimetostat 400 mg plus darolutamide for the Himalayas-1 Phase 3 trial in post-abiraterone mCRPC, expected to start in 1H 2026. The company reported early efficacy and safety data and said cash runway extends into 2H 2028.
The radioligand therapeutics market in cancer treatment is estimated to grow from $2.6 billion in 2025 to $4.8 billion by 2030 at a 13.1% CAGR. Growth is supported by approved products Pluvicto and Lutathera and expanding use of PSMA and SSTR-targeted therapies.
The global radioligand therapy market is projected to grow from $2.6 billion in 2025 to $4.8 billion by 2030 at 13.1% CAGR, driven by FDA label expansions, earlier-line treatment positioning, and substantial private investment in isotope production infrastructure.
Pluvicto (lutetium-177 vipivotide tetraxetan) received MHRA authorization for earlier use in metastatic castration-resistant prostate cancer, while pooled trial data demonstrates improved progression-free survival without increased toxicity.
Novartis announced plans to establish a 46,000-square-foot radioligand therapy manufacturing site in Denton, Texas, as part of its $23 billion US expansion. The facility is expected to be operational in 2028.
Former Novartis executive John Tsai has been appointed global head of R&D at Daiichi Sankyo, replacing Ken Takeshita effective April 1. Tsai brings over 25 years of leadership experience in drug development.
Radiopharmaceuticals are emerging as a promising therapeutic class in oncology, with theranostic approaches combining diagnostics and treatment gaining particular attention. Major pharmaceutical companies have invested billions in acquisitions while venture financing reached record levels.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT06084338 |
Randomized Phase II Trial of Targeted Radiation With no Castration for Mcrpc |
RECRUITING | PHASE2 |
