Novartis announced in a news release that it has resumed production of 177Lu-PSMA-617 (lutetium Lu 177 vipivotide tetraxetan; Pluvicto), along with screening and enrollment for all global clinical trials of the targeted radioligand therapy.1
177Lu-PSMA-617 is FDA-approved for the treatment of patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC).
The company has also resumed production and clinical trials (US and Canada) of another of its radiopharmaceuticals, lutetium Lu 177 dotatate (Lutathera), which is FDA-approved for the treatment of patients with gastroenteropancreatic neuroendocrine tumors.
Novartis announced in May 2022 that it had taken voluntary action in temporarily suspending the clinical trials, as well as activity at its production sites in Ivrea, Italy, and Millburn, New Jersey, to address potential quality issues in the company’s production processes.2
In today’s news release announcing that production had resumed at these facilities, the company noted that it “has remediated the issues that led to the temporary, voluntary suspension of production in May.”
Novartis added, “We recognize that this situation has affected—and is still affecting—patients, their families and care teams. Product quality and patient safety remain the company’s top priorities. We expect that product supply may be initially limited, and we are working hard to resume full production capacity and meet patient demand as quickly as possible. We continue to communicate with health authorities, and they are aware that we have restarted production and that the delivery of patient doses has resumed.”
FDA approval 177Lu-PSMA-617
177Lu-PSMA-617 (also known as LuPSMA) is specifically approved by the FDA for the treatment of patients with PSMA-positive mCRPC in the post androgen receptor pathway inhibition, post taxane-based chemotherapy setting.3
The approval of LuPSMA is based on findings from the phase 3 VISION trial. In the study, adding LuPSMA to standard of care (SOC) led to a nearly 40% reduction in the risk of death versus SOC alone in patients with progressive PSMA-positive mCRPC.4
The findings, which were presented during the 2021 ASCO Annual Meeting, showed that at a median follow-up of 20.9 months, the addition of LuPSMA improved the median overall survival (OS) by 4 months over SOC alone (HR, 0.62). Adding the targeted radioligand therapy also led to a 5.3-month improvement in median radiographic progression-free survival (rPFS), translating to a 60% reduction in the risk of progression or death (HR, 0.40).
Along with the approval of LuPSMA, the FDA also approved a kit for the preparation of gallium Ga 68 gozetotide injection (trade name for kit, Locametz). Following radiolabeling, this imaging agent can identify PSMA-positive lesions through a PET scan.
1. Novartis resumes production and delivery of radioligand therapy medicines ahead of schedule. Published online June 30, 2022. Accessed June 30, 2022. https://bit.ly/3Oy6jYL
2. Novartis provides update on production of radioligand therapy medicines. Published online May 5, 2022. Accessed May 6, 2022. https://bit.ly/3yeMFM6
3. Novartis Pluvicto™ approved by FDA as first targeted radioligand therapy for treatment of progressive, PSMA positive metastatic castration-resistant prostate cancer. March 23, 2022. https://www.novartis.com/news/media-releases/novartis-pluvictotm-approved-fda-first-targeted-radioligand-therapy-treatment-progressive-psma-positive-metastatic-castration-resistant-prostate-cancer
4. Morris MJ, De Bono JS, Chi KN, et al. Phase 3 study of lutetium-177-PSMA-617 in patients with metastatic castration-resistant prostate cancer (VISION). J Clin Oncol 39, 2021 (suppl 15; abstr LBA4)