Novartis subsidiary Advanced Accelerator Applications has obtained approval from the US Food and Drug Administration (FDA) for new drug application (NDA) of its Lutathera to treat gastroenteropancreatic neuroendocrine tumours (GEP-NETs).
Indicated for adults with somatostatin receptor-positive GEP-NETs, Lutathera is said to be the first radioactive drug approved for GEP-NET treatment.
The drug binds to the somatostatin receptor found on certain cancers and enters the tumour cells to facilitate damage to these cells through radiation.
FDA Oncology Center of Excellence director Richard Pazdur said: 鈥淕EP-NETs are a rare group of cancers with limited treatment options after initial therapy fails to keep the cancer from growing.
鈥淭his approval provides another treatment choice for patients with these rare cancers. It also demonstrates how the FDA may consider data from therapies that are used in an expanded access programme to support approval for a new treatment.鈥�
The FDA approval is based on the findings from a randomised clinical trial performed in 229 advanced somatostatin receptor-positive GEP-NET patients who were administered with Lutathera and drug octreotide combination.
Results from this trial showed longer progression-free survival with the combination compared to octreotide monotherapy.
The risk of tumour growth or patient death was found to be comparatively lower in patients who received treatment with the combination.
The FDA also reviewed results from a separate 1,214-subject trial conducted in the Netherlands. It was observed that 16% of a subset of 360 subjects experienced complete or partial tumour shrinkage with Lutathera.
Lutathera currently holds priority review and orphan drug designations issued by the FDA.
