FDA Approves Novartis' Expanded Pluvicto Production Amid Supply Shortage

On April 21, Novartis announced that the FDA had approved its plant in Millburn, New Jersey, to produce the radioligand therapy Pluvicto for commercial use in the United States.

Pluvicto was approved by the FDA in March 2022 for third-line treatment of PSMA-positive metastatic castration-resistant prostate cancer, becoming the world's first targeted PSMA radioligand therapy. In just nine months on the market, Pluvicto generated $271 million in revenue.

For Novartis and many patients with advanced prostate cancer awaiting treatment, this approval is a much-needed victory, as a production shortage of Pluvicto has left prostate cancer patients unable to receive the treatment they need. Due to unexpectedly high demand, Novartis recently paused the initiation of new patients on Pluvicto. Doctors have reported that treatments for existing patients have also been repeatedly delayed.

According to the FDA's update, the estimated shortage period for Pluvicto is approximately three months. A months-long shortage has evidently created a sense of urgency for the FDA, which is why they did not follow the standard four-month review process but instead approved the Millburn facility in less than two months.

Novartis did not specify when it would restart the application of Pluvicto for new patients. A Novartis spokesperson revealed in a statement to Fierce Pharma that they are communicating with doctors and treatment centers, "to help them understand how the gradually increasing supply will affect existing and new prescriptions, as well as our expectations for scheduling in the second half of this year."

Novartis stated that the production at the new Milburn plant "will commence in the coming weeks and ramp up gradually," which also implies that Novartis may need some time to address the supply constraints of Pluvicto.

Novartis added in the press release: "This production base is expected to make a meaningful contribution to the supply and sales of Pluvicto in the third quarter of this year. Production capacity should continue to increase in the second half of the year, helping to ensure a stable and reliable supply for patients."

Since Pluvicto was approved by the FDA and launched in March 2022, Novartis has been supplying this radiopharmaceutical therapy from a plant in Italy. Novartis stated that the facility will continue to manufacture Pluvicto for the U.S. market and is further expanding its production capacity.

In addition, Novartis expects to open a new plant in Indiana as early as the end of this year. Another plant located in Spain has been approved to supply the drug to the EU market. With the support of these new plants, Novartis aims to supply at least 250,000 doses of Pluvicto annually by 2024 and beyond.

In December 2022, the Phase III PSMAfore study of Pluvicto for second-line treatment of PSMA-positive metastatic castration-resistant prostate cancer succeeded. If the treatment line of Pluvicto can be moved forward, the applicable population and market share will further expand. Novartis is quite optimistic about the prospects of Pluvicto and expects it to potentially reach a sales peak of $2 billion.

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