- US FDA has classified drug shortage status as resolved1
- Novartis capacity to produce Pluvicto will continue to grow with anticipated expansions to the manufacturing network in the US and globally
- More than 200 centers are actively ordering doses of Pluvicto for patients in need, with plans to onboard approximately 130 more
Reno, Nevada (UroToday.com) -- Novartis announced that the US Food and Drug Administration has classified the Pluvicto® (lutetium Lu 177 vipivotide tetraxetan) drug shortage status as resolved. This determination is the result of efforts to significantly scale up production of Pluvicto that have more than doubled weekly production capacity since May. Novartis is committed to providing a consistent, reliable supply of Pluvicto and making this important medicine readily available to patients.
“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,” said Victor Bulto, President, Novartis US. “Radioligand therapies have the potential to shift the standard of care in oncology and we are excited about the possibilities of our broad RLT pipeline for patients. 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.”Following FDA approval for commercial production of Pluvicto at the Novartis RLT manufacturing facility in Millburn, New Jersey earlier this year, supply is now unconstrained. Having doubled weekly production, Novartis currently has more than sufficient supply to treat patients within two weeks of diagnosis, which is important for these patients with advanced disease who may need treatment quickly. Pluvicto supply availability should continue to increase into 2024 as Novartis builds additional capacity by expanding production lines at the Millburn, New Jersey site, as well as the new state-of-the-art RLT facility in Indianapolis, Indiana. This site has started clinical production of Pluvicto and, pending FDA approval, will also manufacture commercial doses.
Novartis is expanding access to its RLTs in the US by partnering with treatment sites to add more central locations for patients. As of October, there are more than 200 facilities in the US certified to administer the company’s RLTs. Novartis plans to onboard approximately 130 more certified facilities, strengthening access for more eligible patients across the country.
The company’s RLT manufacturing facility in Ivrea, Italy will continue to supply patients in and outside the US while the facility in Zaragoza, Spain will solely supply patients outside of the US, and Novartis has a vision to add more RLT manufacturing locations around the world. With four active facilities by 2024 and an anticipated combined annual capacity target of at least 250,000 RLT doses in 2024 and beyond, Novartis is committed to providing adequate supply for current and future demand as ongoing clinical trials may present the potential to bring Pluvicto to more patients.
References:
- US Food and Drug Administration (FDA). FDA Drug Shortages: Current and Resolved Drug Shortages and Discontinuations Reported to FDA.