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NCCN, SNMMI Update Guidelines to Expand PET Imaging Agents for Pluvicto Eligibility

NEW YORK – The National Comprehensive Cancer Network (NCCN) told oncologists on Tuesday that they can use a broader range of PET imaging agents to determine which patients are eligible for Novartis' radiopharmaceutical Pluvicto (177Lu-PSMA-617).

In its latest prostate cancer treatment guidelines, NCCN now recommends that gallium 68- or fluorine-18-based PSMA PET imaging can be used to screen patients for Pluvicto eligibility. The Society of Nuclear Medicine and Molecular Imaging (SNMMI) made the same update to its appropriate use guidelines.

To be eligible for Pluvicto, metastatic castration-resistant prostate cancer (mCRPC) patients must have at least one lesion that expresses the prostate-specific membrane antigen (PSMA).

When the US Food and Drug Administration approved Pluvicto in March, it listed gallium-68-based PET imaging with Novartis' Locametz (gallium Ga 68 gozetotide) as a method for screening patients for these PSMA-positive cancers.

Gallium-based PET imaging, however, is not the only radiolabeled method for confirming PSMA positivity. The radioactive agent fluorine-18 can also make PSMA-positive tumors show up on a PET scan.

The NCCN's recommendations now extend to Lantheus Holdings' Pylarify (piflufolastat F18), which is FDA approved for prostate cancer staging and for determining recurrence in PSMA-positive prostate cancer patients. It is not, however, FDA approved as a screening method for Pluvicto. The NCCN guidelines go beyond FDA labeling language and expand the options by which patients can be screened for treatment.

Following Pluvicto's approval, experts in radionuclide therapy voiced concerns about gallium 68 accessibility, since it has historically been more difficult to procure than fluorine-18. Since Pylarify is easier to come by than Locametz, providers want to use it and make Pluvicto available to more patients.

Novartis also has indicated that it wants fluorine-18 to be an option for screening patients for Pluvicto. Shortly after Pluvicto's approval, the drugmaker inked a deal with Lantheus to use Pylarify in future Pluvicto clinical trials.

Although the updated NCCN guidelines might be welcome news for radiation oncologists hoping to offer Pluvicto to as many eligible patients as possible, it may not make much of a difference at present, since Novartis last week announced it was temporarily pausing Pluvicto production at sites in New Jersey and Italy due to possible quality issues.