FDA Classifies 177Lu Vipivotide Tetraxetan Drug Shortage as Resolved

The FDA has announced that there is no longer a shortage of lutetium ¹⁷⁷Lu vipivotide tetraxetan (Pluvicto; ¹⁷⁷Lu-PSMA-617)in the United States, and that the targeted radioligand will be available to treat select patients with prostate cancer within two weeks of diagnosis, according to a press release by Novartis.¹ 

The announcement came after weekly production capacity of ¹⁷⁷Lu vipivotide tetraxetan than doubled since May 2023. Experts anticipate that the supply of ¹⁷⁷Lu vipivotide tetraxetan will continue to increase into 2024, as production capability will be increased at a facility in New Jersey and a new facility in Indiana is set to open. The current facility is focused on clinical production of the agent, although production of commercial doses is expected following the FDA approval of ¹⁷⁷Lu vipivotide tetraxetan.

Novartis is also partnering with several treatment sites to increase access to treatment with radioligand therapeutics. Currently, there are 200 facilities certified to administer ¹⁷⁷Lu vipivotide tetraxetan, and 130 more are planned to be onboarded.

“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,” Victor Bulto, president of Novartis US, said in the press release. “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.”

The drug shortage of ¹⁷⁷Lu vipivotide tetraxetan was declared by the FDA on March 7, 2023 and lasted through to October 25, 2023.²

The FDA approved ¹⁷⁷Lu vipivotide tetraxetan for prostate-specific membrane antigen (PSMA)–positive metastatic castration-resistant prostate cancer (mCRPC) among patients who have previously undergone treatment with an androgen receptor pathway inhibitor and taxane-based chemotherapy.³ The approval was based on data from the phase 3 VISION trial (NCT03511664).

Findings from the study, which were presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, indicated that ¹⁷⁷Lu vipivotide tetraxetan resulted in a 40% reduction in risk of death at a median follow-up of 20.9 months. Investigators also reported a 4-month overall survival benefit over standard of care (HR, 0.62). Moreover, the agent resulted in a 60% decrease in the risk of progression or death (HR, 0.40).

The study included a population of 831 of 1179 patients who were initially screened. Patients had been diagnosed with PSMA-positive disease and underwent treatment with a minimum of 1 novel androgen axis agent such as enzalutamide (Xtandi) or abiraterone acetate (Zytiga). They also need to have previously received 1 to 2 taxane-based regimens.

Those who enrolled were randomly assigned 2:1 to be treated with either ¹⁷⁷Lu vipivotide tetraxetan at a dose of 7.4 GBq every 6 weeks for 6 cycles (n = 551) plus standard of care or standard of care by itself (n = 280).

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 27, 2023. https://bit.ly/49mWjMS
2. FDA drug shortages. FDA. Revised October 24, 2023. Accessed October 31, 2023. https://bit.ly/40lcru1
3. Novartis Pluvicto approved by FDA as first targeted radioligand therapy for treatment of progressive, PSMA positive metastatic castration-resistant prostate cancer. News release. Novartis. March 23, 2022. Accessed October 31, 2023. https://bit.ly/36lu4Ct
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. 2021;39(suppl 18):LBA4.doi:10.1200/JCO.2021.39.15_suppl.LBA4