Novartis secures FDA approval for Pluvicto production at US plant

2024-01-08

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Novartis secures FDA approval for Pluvicto production at US plant

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来源: Pharmaceutical Technology

Novartis is also exploring a wide range of RLTs for cancers. Credit: Michael Derrer Fuchs/ shutterstock.com.

Novartis has received US Food and Drug Administration (FDA) approval to commercially manufacture Pluvicto at its new radioligand therapy (RLT) manufacturing facility.

The Indianapolis site is purpose-built for RLT production, with plans for fully automated lines.

It will supply the US and, subject to approval, Canada, complementing the existing Millburn, New Jersey facility.

The expansion of the RLT manufacturing network supports the potential reach of Pluvicto and Lutathera to more patients at earlier treatment stages.

Novartis’ RLT platform provides cancer treatment by targeting radiation delivery to cancer cells throughout the body.

The company is also exploring a wide range of RLTs for cancers, including breast, colon, lung and pancreatic, beyond its current focus on gastroenteropancreatic neuroendocrine tumours and prostate cancer.

Novartis operations president Steffen Lang stated: “Adding a second US 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.

“We also recently announced plans to build our manufacturing capabilities in Sasayama, Japan and Haiyan, Zhejiang, China, as we continue to look for opportunities to further expand our worldwide reach.”

Shanghai Argo Biopharmaceutical has also signed two licensing and collaboration deals with Novartis Pharma.

Argo will receive an initial payment of $185m from Novartis, with the possibility of additional option and milestone payments and royalties on future sales.

Novartis has secured an exclusive licence outside of Greater China for a Phase 1/2a cardiovascular programme and a global exclusive licence for a Phase I cardiovascular programme.

Novartis also has the option to license compounds targeting up to two cardiovascular diseases.

These agreements leverage Argo’s RNAi [ribonucleic acid interference] technology to bolster Novartis’s cardiovascular and metabolic diseases RNAi portfolio.

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