FDA agrees to review generic of Novartis radoligand therapy Lutathera

2024-01-11

上市批准并购

Lantheus announced Thursday that the FDA has accepted its application to market a generic version of Novartis' Lutathera (lutetium Lu 177 dotatate). The radiopharmaceutical is currently approved in the US as a treatment for somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours (NETs)somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours (NETs) in adults.

If the FDA signs off on the generic version, dubbed 177Lu-PNT2003, Lantheus said it believes it would be the first applicant to have filed a substantially complete ANDA for Lutathera containing a Paragraph IV certification under provisions of the Hatch-Waxman Act, and that it would be eligible for 180 days of generic marketing exclusivity in the US.

Lutathera became the first peptide receptor radionuclide therapy to secure approval when the FDA signed off on it in 2018. That decision was based on pivotal NETTER-1 data showing that adding it to standard care with octreotide LAR led to a 79% reduction in the risk of disease progression or death in patients with inoperable midgut NETs, compared to octreotide LAR alone. The treatment was originally developed by Advanced Accelerator Applications, which was subsequently acquired by Novartis for around $3.9 billion.

Lantheus licensed commercialisation rights to 177Lu-PNT2003, along with another radiotherapeutic agent, from POINT Biopharma at the end of 2022 for up to $2.2 billion. Earlier this week, Lantheus also paid $28 million upfront for an option to exclusively license Perspective Therapeutics' radiopharmaceutical Pb212-VMT-⍺-NET, which is in a Phase I/II trial to treat NETs.

Meanwhile, Novartis has been working to boost its manufacturing capabilities for radioligand therapies, including the prostate cancer treatment Pluvicto (lutetium 177 vipivotide tetraxetan). Last week, the company announced that the FDA had authorised a new production facility in Indianapolis, Indiana.

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