Novartis has announced that the FDA has resolved the drug shortage status for Pluvicto (lutetium Lu 177 vipivotide tetraxetan). The development comes after Novartis significantly scaled up production, more than doubling its weekly production capacity since May.
The company initially halted production of Pluvicto (lutetium Lu 177 vipivotide tetraxetan) along with Lutathera (USAN: lutetium Lu 177 dotatate; INN: lutetium (177Lu) oxodotreotide in the U.S. and Canada in mid-2022 over possible quality concerns. The company restarted production soon thereafter.
Pluvicto is a radiopharmaceutical medication for prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer. Lutathera is indicated for gastroenteropancreatic neuroendocrine tumors.
Burgeoning demand for Pluvicto
Pluvicto is approved in the U.S., the European Union, and other countries to treat adults with advanced PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) who have already been treated with other anticancer treatments. Clinical trials are ongoing to evaluate Pluvicto in earlier stages of prostate cancer.
Novartis notes that it plans to expand its manufacturing network for Pluvicto in the U.S. and globally.
The company notes that more than 200 centers are actively ordering doses of Pluvicto, with plans to onboard roughly 130 more. Novartis has also received FDA approval for commercial production of Pluvicto at its manufacturing facility in Millburn, New Jersey.
Novartis intends to expand capacity at the Millburn site and has also started clinical production in Indianapolis, Indiana.
Will Novartis’ Pluvicto succeed in earlier prostate cancer treatment?
Pluvicto recently showed mixed results in a clinical trial for earlier-stage prostate cancer. In the phase 3 PSMAfore trial, Pluvicto cut the risk of disease progression or death by 57% compared to androgen receptor inhibitor in patients with PSMA-positive, metastatic castration-resistant prostate cancer who hadn’t received taxane-based chemotherapy.
The results also suggested a 16% increased risk of death in patients treated with Pluvicto. After adjusting for crossover treatments, Pluvicto posted a 20% reduction in the risk of death compared to the control group, but these results were deemed immature.
The results could cast uncertainty over Pluvicto’s regulatory path forward as Novartis plans on moving the drug into earlier treatment settings for prostate cancer. The company plans to share its regulatory strategy for Pluvicto during its third-quarter earnings report.