Novartis has temporarily suspended production of 177Lu-PSMA-617 (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 also halted 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.
Stopping the manufacturing of these 2 radioligand therapies involves suspending activity at Novartis’s production sites in Ivrea, Italy, and Millburn, New Jersey. Novartis reported in a news release that it took the voluntary action to address potential quality issues in the company’s production processes. The company has set a target goal of 6 weeks to resolve the issues and restart at least some manufacturing of the radiopharmaceuticals.
“Quality and patient safety are our top priorities. There is currently no indication of any risk to patients from doses previously produced at these sites. Novartis has notified treatment sites to closely monitor patients who have recently been injected and asked them to report any adverse events to Novartis patient safety,” the company reported the news release.
“We recognize that this situation affects patients, their families and care teams. Novartis takes this very seriously and the company is doing everything it can to resolve this issue and resume patient doses as quickly as possible. Health authorities have been informed and will receive additional updates as they are available,” Novartis added in its statement.
FDA approval 177Lu-PSMA-617
177Lu-PSMA-617 (also known as LuPSMA and lutetium Lu 177 vipivotide tetraxetan) 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.2
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.3
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 provides update on production of radioligand therapy medicines. Published online May 5, 2022. Accessed May 6, 2022. https://bit.ly/3yeMFM6
2. 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
3. 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).