Novartis’ Lutathera is now the first radiopharmaceutical approved for adolescents with a rare cancer found in the gut.
The radioligand therapy won a label expansion on Tuesday for patients 12 years and older with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors, or GEP-NETs. Neuroendocrine tumors are exceedingly rare, with only a few thousand diagnoses per year in the US, according to MD Anderson.
The expansion was based on a small open-label trial of patients 12 to 17 years old, as well as data from a larger trial that supported Lutathera’s original approval. Novartis acquired Lutathera in its $3.9 billion deal for Advanced Accelerator Applications, then won an approval for adults with GEP-NETs in 2018. In connection with the label expansion, regulators have issued a new post-marketing requirement to assess Lutathera’s long-term safety in adolescents.
The decision came shortly after Novartis announced its first-quarter financial results, including $169 million in US Lutathera sales, up 14% from last year. CEO Vas Narasimhan hopes to grow outside of the US as well, with plans for new manufacturing facilities in Japan and China “to support the Pluvicto and Lutathera businesses,” according to an AlphaSense transcript of the investor call.
The company’s stock $NVS was up 2% on Tuesday afternoon, pricing at $97.33 per share.
“This approval, bringing a first-of-its-kind treatment option to patients in need, underscores why Novartis is investing in and committing to expanding our radioligand therapy portfolio,” a Novartis spokesperson told Endpoints News on Tuesday.