Curium gains FDA nod for Bexlutry as it eyes challenge to Novartis radioligand therapies

Curium recently received FDA approval for its radiopharmaceutical Bexlutry, positioning it as a direct competitor to Novartis’ Lutathera.

The biotech is also in discussions with the FDA about filing another radiopharma candidate that could challenge Novartis’ Pluvicto, while Telix Pharmaceuticals plans to acquire ITM Isotope Technologies for $1.65 billion, adding therapies that may compete with both Novartis products.

Novartis’ Lutathera and Pluvicto together generated $1.7 billion in the first half of the year, and rising competition could increase pressure on the Swiss drugmaker’s growth outlook.

However, entering the radioligand therapy market requires more than regulatory approval; manufacturers must secure a reliable supply of lutetium‑177 and develop a resilient production footprint, challenges Curium acknowledges as it outlines three steps to compete.