Tuesday, April 16, 2024

Novartis Ensures Unrestricted Pluvicto® Supply and Expands Treatment Centers

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Novartis has announced that the US Food and Drug Administration (FDA) has classified the Pluvicto® (lutetium Lu 177 vipivotide tetraxetan) drug shortage status as resolved. This decision follows extensive efforts to significantly increase the production of Pluvicto, which has seen weekly production capacity more than double since May. Novartis is committed to ensuring a consistent and reliable supply of Pluvicto, an essential medicine for patients with advanced cancer.

The increase in production capacity is a response to the growing demand for radioligand therapies (RLTs) like Pluvicto, which show promise in the treatment of oncology patients. To meet this demand, Novartis has obtained FDA approval for commercial production of Pluvicto at its RLT manufacturing facility in Millburn, New Jersey. The supply is now unconstrained, with Novartis having enough stock to treat patients within two weeks of diagnosis, a crucial timeline for those with advanced diseases who require prompt treatment.

Novartis plans to further boost Pluvicto’s supply availability in 2024 by expanding its production capabilities. This expansion includes adding production lines at the Millburn, New Jersey site and opening a new state-of-the-art RLT facility in Indianapolis, Indiana, which has already started clinical production of Pluvicto. Pending FDA approval, the Indianapolis facility will also manufacture commercial doses.

To ensure greater patient access to RLTs in the United States, Novartis is partnering with treatment sites to establish more central locations for patients. Over 200 certified facilities in the US can now administer Novartis’s RLTs, with approximately 130 more facilities expected to be onboarded. This expansion aims to provide eligible patients across the country with improved access to these therapies.

Novartis’s global commitment to RLT manufacturing is evident through its facilities in Ivrea, Italy, which will continue to supply patients in and outside the US, and Zaragoza, Spain, which will exclusively supply patients outside of the US. Novartis plans to establish more RLT manufacturing locations worldwide, with a goal of having four active facilities by 2024 and a combined annual capacity of at least 250,000 RLT doses in 2024 and beyond. This commitment ensures an adequate supply of Pluvicto to meet current and future demand, particularly as ongoing clinical trials may expand its use to more patients.

Pluvicto is an intravenous radioligand therapy used to treat PSMA-positive metastatic castration-resistant prostate cancer in patients who have already received other anticancer treatments. Novartis’s expansion efforts aim to make this vital therapy readily available to all eligible patients and further advance the treatment landscape for advanced cancer patients.

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