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# Novartis Seeking Expanded Pluvicto Use
- URL: https://www.fdaweb.com/novartis-seeking-expanded-pluvicto-use/
- Published: 2022-12-05T12:00:00.000Z
- Updated: 2026-09-14T18:08:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153319

Novartis says it will seek FDA approval next year for an expanded use for Pluvicto (lutetium Lu 177 vipivotide tetraxetan) — to slow disease progression in patients with prostate-specific membrane antigen (PSMA)–positive metastatic castration-resistant prostate cancer after treatment with androgen receptor pathway inhibition (ARPI) and before taxane-based chemotherapy. The drug is currently approved for treating adults with PSMA-positive metastatic castration-resistant prostate cancer who have been treated with ARPI and taxane-based chemotherapy. The expanded indication will be based on Phase 3 data demonstrating a statistically significant and clinically meaningful improvement in radiographic progression-free survival, according to the company.

Novartis says Pluvicto is the first PSMA-targeted radioligand therapy to demonstrate clinically meaningful benefits for patients with this type of prostate cancer who have not received taxane-based chemotherapy. “Despite recent advances, outcomes for those who progress after standard of care second-generation ARPI remain poor, and there is an urgent need for new targeted treatment options to help improve long-term outcomes,” it says.

Pluvicto is described as an intravenous radioligand therapy combining a targeting compound (a ligand) with a therapeutic radionuclide (a radioactive particle, in this case lutetium-177). “After administration into the bloodstream, Pluvicto binds to target cells, including prostate cancer cells that express PSMA, a transmembrane protein,” Novartis says. “Once bound, energy emissions from the radioisotope damage the target cells and nearby cells, disrupting their ability to replicate and triggering cell death.”