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Novartis, Lantheus Partner on PSMA Imaging-Based Patient Selection in Pluvicto Trials

NEW YORK – Lantheus Holdings and Novartis on Tuesday announced a partnership to use Lantheus' prostate-specific membrane antigen (PSMA)-directed imaging agent Pylarify (piflufolastat F 18) as a patient selection tool for clinical trials of Novartis' Pluvicto (lutetium Lu 177 vipivotide tetraxetan).

Under the terms of the agreement, Lantheus will provide Pylarify — a fluorine 18-based PET imaging agent designed to illuminate PSMA-positive tumors — for identifying PSMA-positive metastatic castration-resistant prostate cancer patients who can receive Pluvicto within clinical trials. In exchange, Novartis will provide Lantheus with Pylarify-related clinical imaging data from the trials.

Novartis recently garnered US Food and Drug Administration approval for its PSMA-targeted radiopharmaceutical Pluvicto in previously treated PSMA-positive mCRPC patients. Simultaneously, the agency also approved Novartis' gallium-68-labeled imaging product Locametz (gallium Ga 68 gozetotide) to identify mCRPC patients with PSMA-positive lesions who can receive Pluvicto. The FDA-approved label for Pluvicto states that patients eligible for treatment should be identified using Locametz or another approved PSMA-11 (gallium Ga 68 gozetotide) imaging agent.

Novartis is actively conducting clinical trials to move Pluvicto into additional treatment lines. In partnering with Novartis, Lantheus hopes to explore how PSMA PET imaging agents like Pylarify can increase patient access to PSMA-targeted therapies. Some have expressed concern in light of Pluvicto's approval that gallium-based PSMA-11 imaging might not be accessible to all patients who might benefit from treatment.

Last year, the FDA approved Pylarify as a PET imaging agent for identifying PSMA-positive lesions in mCRPC patients. But if Pylarify is approved alongside additional Pluvicto indications, it will offer doctors another FDA-reviewed radioactive imaging agent with which to identify treatment eligible patients.

According to a statement from Lantheus, the firm believes that the recent approval of Novartis' radiopharmaceutical will increase demand for PSMA PET imaging. The company estimates that with Pluvicto on the market, PSMA PET imaging will increase by roughly 30,000 de novo scans per year, yielding a $1.1 billion market opportunity.