FDA classifies 177Lu-PSMA-617 drug shortage as resolved

The FDA has marked the 177Lu-PSMA-617 (Pluvicto) drug shortage status as resolved given unconstrained supply of the prostate cancer agent, announced Novartis, the developer of the therapy, in a news release.¹

177Lu-PSMA-617 was approved in 2022 based on findings from the phase 3 VISION trial.

According to the release, Novartis is now equipped to provide 177Lu-PSMA-617 to patients within 2 weeks of diagnosis with advanced disease.

To meet demand, the company noted that they doubled their weekly production of 177Lu-PSMA-617, and they currently have plans to further expand their production lines at their Millburn, New Jersey site and their new radioligand therapy (RLT) facility in Indianapolis, Indiana. The company has also partnered with other treatment sites to add more central locations for RLT access. As of this month, the company reported that more than 200 facilities in the US are certified to administer 177Lu-PSMA-617, with plans to onboard 130 more across the country.

The company also clarified that their manufacturing facility in Ivrea, Italy will continue to supply patients in and outside the US. The facility in Zaragoza, Spain will solely supply to patients outside of the US. Novartis hopes to have 4 active facilities by 2024 to help achieve their combined annual capacity target of at least 250,000 doses of the therapy in 2024 and beyond.

Victor Bulto, president of Novartis US, said in the news release, “We have been working hard to increase the capacity and improve the reliability of the supply of our radioligand therapies to ensure patients have access to this therapy and to prepare for future growth as more patients may become eligible for this treatment. Radioligand therapies have the potential to shift the standard of care in oncology and we are excited about the possibilities of our broad RLT pipeline for patients. With substantial experience in developing a reliable supply chain and delivery infrastructure, we are well positioned to expand access to these therapies for years to come.”

Data on 177Lu-PSMA-617

177Lu-PSMA-617 is approved in the US for the treatment of adult patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) who have been previously treated with androgen receptor pathway inhibition and taxane-based chemotherapy.²

The agent was approved in 2022 based on findings from the phase 3 VISION trial (NCT03511664), which showed that adding 177Lu-PSMA-617 to standard of care (SOC) in patients with PSMA-positive mCRPC led to a nearly 40% reduction in the risk of death vs SOC alone. Specifically, the addition of 177Lu-PSMA-617 improved the median overall survival by 4 months over SOC alone at 15.3 vs 11.3 months, respectively (HR, 0.62; P < .001).²

Currently, there are multiple phase 3 studies ongoing to further assess 177Lu-PSMA-617, including PSMA-DC (NCT05939414) in the oligometastatic setting, PSMAddition (NCT04720157) in the metastatic hormone-sensitive setting, and PSMAfore (NCT04689828) in the pre-taxane mCRPC setting, which reported findings at a recent medical conference. Data from the phase 3 PSMAfore trial showed that the study met its primary end point of radiographic progression-free survival (HR, 0.43; 95% CI, 0.33-0.54; P < .001) and showed a favorable safety profile in patients with mCRPC who were taxane-naïve.³ All trials remain ongoing.

References

1. Novartis confirms unconstrained supply for Pluvicto and continues to significantly expand the number of treatment centers. News release. Novartis. October 26, 2023. Accessed October 30, 2023. https://www.novartis.com/news/media-releases/novartis-confirms-unconstrained-supply-pluvicto-and-continues-significantly-expand-number-treatment-centers

2. US Food & Drug Administration. FDA approves Pluvicto for metastatic castration-resistant prostate cancer. Published online March 23, 2022. Accessed October 30, 2023. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pluvicto-metastatic-castration-resistant-prostate-cancer

3. Sartor AO, Castellano D, Herrmann K, et al. Phase III trial of [177Lu]Lu-PSMA-617 in taxane-naive patients with metastatic castration-resistant prostate cancer (PSMAfore). Presented at: ESMO Congress 2023; October 20-24, 2023; Madrid, Spain. Abstract LBA13