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FDA gives nod to Novartis' Indianapolis RLT facility for production and sale of Pluvicto

por John R. Fischer, Senior Reporter | January 11, 2024
Molecular Imaging
Novartis has gotten FDA approval for manufacturing and commercialization at its RLT facility in Indiannapolis for Pluvicto.
The FDA has given Novartis the green light to begin manufacturing and commercializing Pluvicto out of what will be its largest and most advanced radioligand therapy manufacturing facility, to date, in Indianapolis.

Approved in 2022, Pluvicto treats metastatic prostate cancer in patients who have already undergone androgen receptor pathway inhibition, chemotherapy, and other cancer treatments and has been proven to increase overall survival. It combines a targeting compound or ligand with a radioactive particle, emitting a small amount of ionizing beta radiation to the tumor from a short distance away to avoid hitting surrounding healthy tissue. Each dose must be delivered within five days or will fail to work effectively.

The 70,000-square-foot facility is designed specifically for RLT manufacturing, increasing production capacity to 250,000 doses in 2024 and beyond. The FDA predicted it to play a key role in supply growth in 2024 after unplanned manufacturing events and doses not arriving in time last spring caused Novartis to halt delivery of regimens for new patients for three months or longer for months on end. The shortage was only recently resolved in October.
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In the wake of it, the company increased weekly production at its sites in Millburn, New Jersey; Ivrea, Italy; and Zaragoza, Spain, making its Pluvicto supply “unconstrained,” with more than enough to treat patients within two weeks of diagnosis. This amount is expected to grow with the new facility, which features space for continued line expansion including plans for fully automated lines, a first for the radiopharmaceutical industry.

“The intricate process of providing RLTs to patients within hours of production requires precision manufacturing expertise to bring these medicines to individuals who critically need them,” said Steffen Lang, president of operations at Novartis. “Adding a second U.S. RLT facility, our largest and most advanced yet, into our manufacturing network underscores our commitment to ensure a consistent and reliable experience for patients and their healthcare teams for years to come.

Along with the Millburn site, the Indianapolis facility will produce supplies for patients in the U.S. and upon approval, in Canada. The Italian site will also produce supplies for patients in and outside the U.S., while the Spanish one will solely provide RLTs for patients outside the U.S.

in light of ongoing clinical trials that may pave the way for earlier administration of Pluvicto and Lutathera in treatment, the company says it plans to add more sites closer to patients in the coming months. It previously announced that it has partnered with treatment sites to add more than 200 facilities in the U.S. that are certified to administer the company’s RLTs and would onboard approximately 130 more.
It also is planning to build manufacturing facilities in Sasayama, Japan and Haiyan, Zhejiang, China, to increase production overseas.

Along with Pluvicto, Novartis is evaluating a range of diverse RLTs and new isotopes, ligands, and combination therapies for breast, colon, lung, and pancreatic cancer.

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