Pluvicto (lutetium Lu 177 vipivotide tetraxetan)

This FAERS analysis characterizes agent-specific safety profiles, informing pharmacovigilance strategies. Mechanistic profiling of adverse drug reactions optimizes evidence-based treatment, enhancing medication safety and refining benefit-risk profiles in clinical practice.

In recent years, the regulatory approval of radiopharmaceuticals such as [177Lu]Lu-DOTATATE and [177Lu]Lu-PSMA-617, alongside their diagnostic counterparts [68Ga]Ga-DOTATATE and [68Ga]Ga-PSMA-11, has propelled theranostics into the clinical mainstream, marking a transformative shift in nuclear medicine and precision oncology...With their molecular precision, structural versatility, and therapeutic adaptability, cyclic peptides are positioned at the forefront of next-generation radiopharmaceutical development. As the field continues to evolve toward increasingly personalized and molecularly targeted cancer therapies, radiolabeled cyclic peptides are poised to play a pivotal role in redefining the future landscape of radiotherapy.

Multicycle [177Lu]Lu-PSMA-617 and pembrolizumab showed encouraging activity with manageable toxicity that was consistent with [177Lu]Lu-PSMA-617 or pembrolizumab, and the combination might provide durable clinical benefit in a subset of patients.

P1, N=300, Recruiting, Janssen Research & Development, LLC | Trial completion date: Sep 2027 --> May 2028 | Trial primary completion date: Jun 2026 --> Aug 2027

P2, N=130, Active, not recruiting, Novartis Pharmaceuticals | Recruiting --> Active, not recruiting

P1/2, N=123, Recruiting, Novartis Pharmaceuticals | N=73 --> 123

P1, N=20, Active, not recruiting, Weill Medical College of Cornell University | Suspended --> Active, not recruiting | Phase classification: P1/2 --> P1 | N=48 --> 20 | Trial completion date: Dec 2027 --> Dec 2029 | Trial primary completion date: Dec 2026 --> Dec 2027

P1, N=30, Recruiting, University of California, San Francisco | Not yet recruiting --> Recruiting

P=N/A, N=753, Not yet recruiting, Novartis Pharmaceuticals

P=N/A, N=1247, Completed, Novartis Pharmaceuticals

P2, N=87, Active, not recruiting, Novartis Pharmaceuticals | Recruiting --> Active, not recruiting

P2, N=40, Recruiting, Jonsson Comprehensive Cancer Center | Trial completion date: Jan 2027 --> Jan 2028 | Trial primary completion date: Jan 2026 --> Jan 2027