Radioactive drug given approval by the FDA

pharmafile | January 29, 2018 | News story | Sales and Marketing Advanced Accelerator Applications, Lutathera, Novartis, biotech, drugs, pharma, pharmaceutical 

The FDA has approved Lutathera, marking the first time that the agency has given approval for a radioactive drug or ‘radiopharmaceutical’.

The treatment is designed for a rare type of cancer of the pancreas or gastrointestinal tract called gastroenteropancreatic neuroendocrine tumours (GEP-NETs).

The approval comes only days after Novartis had announced the acquisition of the company behind the drug, Advanced Accelerator Applications (AAA). It means that the treatment will now be available in both US and EU territories, adding to Novartis’ existing oncology portfolio whilst also providing them with pipeline candidates.

Lutathera was actually in front of the FDA for a second time, after it had been initially knocked back in 2016 when the agency asked for further study data on the treatment.

In the subsequently submitted application, a study found that the drug reduced risk of disease progression or death by 79% compared to Novartis own drug, Sandostatin. In addition, Lutathera was shown to have an objective response rate, including both complete and partial responses, of 13% compared to just 4% in patients receiving Sandostatin.

Stefano Buono, Advisor and former Chief Executive Officer of Advanced Accelerator Applications, stated, “The approval of Lutathera is the culmination of years of hard work and partnership with numerous physicians and patients. With this approval, AAA’s first theragnostic pairing, based on radiolabeling the same targeting molecule with either lutetium 177 or gallium 68, respectively for therapeutic or diagnostic purposes is complete.”

The FDA noted that one in 27,000 people will be diagnosed with GEP-NETs each year; the treatment has a list price of $47,500 per dose and patients usually receive four doses of the treatment.

It is projected to potentially become a blockbuster treatment, with estimates ranging widely from $500 million to $2 billion in global peak sales.

Novartis’ Sandostatin, the comparator treatment used in trials, achieved sales of $1.6 billion last year and the company will be hoping that Lutathera is able to achieve sales in the upper range of estimates to replace the declining sales of the former drug, which lost patent protection last year.

Ben Hargreaves

Related Content

AstraZeneca and MSD’s Lynparza receives NICE positive recommendation as a cancer maintenance treatment

UK-based pharmaceutical company AstraZeneca has announced that the National Institute for Health and Care Excellence …


Astellas Pharma and BMT CTN announce phase 3 data for gilteritinib

Japanese pharmaceutical company Astellas Pharma and the Blood and Marrow Transplant Clinical Trials Network (BMT …

Novartis Cosentyx® gains positive CHMP opinion for hidradenitis suppurativa

Basel, April 26, 2023 — Novartis announced today that the Committee for Medicinal Products for Human …

Latest content