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# Novartis Seeking Expanded Pluvicto Label
- URL: https://www.fdaweb.com/novartis-seeking-expanded-pluvicto-label/
- Published: 2024-04-04T12:00:00.000Z
- Updated: 2026-09-14T14:27:27.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156708

Novartis says it will seek FDA approval in the second half of this 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 label expansion submission was delayed last year after the company reported that an interim analysis found that the pre-specified crossover-adjusted overall survival (OS) analysis demonstrated a hazard ratio of 0.80\. “The unadjusted intent-to-treat OS analysis was confounded as 84% of patients who discontinued ARPI due to radiographic progression crossed over to receive Pluvicto,” the company said at the time.

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 Novartis. It also says updated OS results from a “pre-planned analysis at approximately 75% information fraction demonstrates an OS hazard ratio less than 1.0 (HR<1.0) in the intent-to-treat population unadjusted for cross-over.”

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.”