177Lu-PSMA-617 production expands with new manufacturing facility

The FDA has approved a new large-scale radioligand therapy (RLT) manufacturing facility in Indianapolis, Indiana for the commercial production of ¹⁷⁷Lu-PSMA-617 (Pluvicto) for prostate cancer, according to a news release by Novartis, the developer of the agent.¹

The company also has plans to build new points of supply for ¹⁷⁷Lu-PSMA-617 in Sasayama, Japan and Haiyan, Zhejiang, China.

The facility, which will serve as the company’s second RLT manufacturing facility in the US, will increase the production capacity of ¹⁷⁷Lu-PSMA-617 to 250,000 doses in 2024 and beyond. The site is also the largest Novartis facility to date, spanning 70,000-square feet.

“The intricate process of providing RLTs to patients within hours of production requires precision manufacturing expertise to bring these medicines to individuals who critically need them. Adding a second US RLT facility, our largest and most advanced yet, into our manufacturing network underscores our commitment to ensure a consistent and reliable experience for patients and their healthcare teams for years to come. We also recently announced plans to build our manufacturing capabilities in Sasayama, Japan and Haiyan, Zhejiang, China, as we continue to look for opportunities to further expand our worldwide reach,” said Steffen Lang, president of operations for Novartis, in the news release.¹

The site in Indianapolis will supply ¹⁷⁷Lu-PSMA-617 to patients in the US and eventually Canada, upon approval, alongside the company’s current facility in Millburn, New Jersey. Novartis also noted that their manufacturing facility in Ivrea, Italy will continue to supply to patients in and outside the US, and the facility in Zaragoza, Spain will solely supply to patients outside of the US. The company also has plans to build new points of supply in Sasayama, Japan and Haiyan, Zhejiang, China.

The announcement of the new facility in Indianapolis comes after the FDA recently classified the ¹⁷⁷Lu-PSMA-617 shortage as resolved in October 2023 given unconstrained supply of the prostate cancer agent. In order to meet demands, the company doubled their weekly production and is now equipped to provide ¹⁷⁷Lu-PSMA-617 to patients within 2 weeks of diagnosis with advanced disease.

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 demonstrated 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 to 15.3 months vs 11.3 months with SOC alone (HR, 0.62; P < .001).²

There are currently 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 expands production of Pluvicto with addition of its largest and most advanced radioligand therapy manufacturing facility in Indianapolis. News release. Novartis. January 5, 2024. Accessed January 8, 2024. https://www.novartis.com/news/media-releases/novartis-expands-production-pluvictotm-addition-its-largest-and-most-advanced-radioligand-therapy-manufacturing-facility-indianapolis?utm_source=pitch&utm_medium=email&utm_campaign=IndyFDA

2. US Food & Drug Administration. FDA approves Pluvicto for metastatic castration-resistant prostate cancer. Published online March 23, 2022. Accessed January 8, 2024. 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