A Radiation Drug That Targets Rare Gut Tumors Gets a New Maker

The US Food and Drug Administration has approved Bexlutry, an injected radiation therapy made by Curium, for adults with a rare group of tumors that begin in the digestive tract and pancreas. Curium announced the approval on Sept. 14, 2026, and said the drug is available for prescribing now.

The therapy carries a radioactive form of the metal lutetium on a molecule that latches onto a docking point these tumors carry in unusual numbers. The radiation is delivered at the tumor rather than across the whole body. The tumors grow from hormone-producing cells scattered through the gut and pancreas, and Curium's release puts them at 60–70% of all neuroendocrine tumors.so which

Bexlutry was approved through the FDA's 505(b)(2) pathway, a route that lets a company rely on published evidence about a drug already on the market instead of repeating the full trial program behind it. The release names Lutathera, which has the same active ingredient, as the product Bexlutry targets, and says the application was supported by bridging data showing a similar biological and chemical profile.

Curium calls Bexlutry the first radioligand equivalent approved for these tumors, a radioligand being a drug that carries radiation to a specific target. The active ingredient is one already approved under another brand name, so the approval adds another version of an existing therapy rather than a new treatment.

The release also reproduces the safety section of the FDA label, which warns of falling blood cell counts, kidney and liver toxicity, and a raised long-term cancer risk from the radiation the drug delivers. Those risks are greater in children than in adults, the label says. Curium's announcement gives no price.