This article has been updated to include the wholesale acquisition costs for Pluvicto and Locametz.
NEW YORK – The US Food and Drug Administration on Wednesday approved Novartis' targeted radioligand therapy Pluvicto (177Lu-PSMA-617 or lutetium Lu 177 vipivotide tetraxetan) for progressive, metastatic castration-resistant prostate cancer (mCRPC) patients whose tumors express the prostate-specific membrane antigen (PSMA).
The agency also approved Novartis' gallium-68-labeled imaging product Locametz (gallium Ga 68 gozetotide) as a companion diagnostic to identify mCRPC patients with PSMA-positive lesions who are eligible to receive Pluvicto. Patients considering treatment will undergo PET imaging after Locametz injection, and the results will indicate whether they are likely to benefit from Pluvicto. More than 80 percent of prostate cancers express high levels of PSMA on their tumors.
To be eligible for the radioligand treatment, patients must also have received an androgen receptor pathway inhibitor and taxane-based chemotherapy.
The FDA based its decision to approve Pluvicto on the results of the Phase III VISION trial, in which previously treated mCRPC patients whose lesions were PSMA-positive according to gallium-68-labeled PET imaging were randomized to either Pluvicto with standard therapy or just standard treatment. The Pluvicto-treated patients experienced improved overall survival and progression-free survival compared to those just on standard therapy. With Pluvicto-based treatment, there was a 38 percent reduction in the risk of death.
Novartis said in a statement that Pluvicto and Locametz will be available to physicians and patients within weeks. However, some in the field have previously questioned whether prostate cancer patients will truly have equitable access to this treatment, given technical and space requirements for administering radioligand therapy as well as its high cost. Pluvicto's wholesale acquisition cost is set at $42,500 per dose. According to a Novartis spokesperson, patients will receive a maximum of six doses, making the maximum list price $255,000. The wholesale acquisition cost for the maximum dose of the imaging product Locametz, meanwhile, is $5,600. According to the spokesperson, Novartis is optimistic that most payors will cover the treatment.
In a call to discuss its 2021 financial results in February, Novartis announced plans to initially roll out the therapy in roughly 225 treatment centers in the US and 200 centers in the EU. Both Pluvicto and Locametz are products of Advanced Accelerator Applications, a subsidiary of Novartis dedicated to radioligands.
Novartis is also evaluating Pluvicto in earlier mCRPC settings in two Phase III studies, and the firm anticipates the treatment will significantly bolster revenues from its oncology portfolio.