Lutetium (177Lu) oxodotreotide

And finally, number seven, Curium wins FDA approval for first ever radioligand equivalent.

And by the way, this is a copycat of Novartis' Lutathera, and it is historic regulatory milestone, opening the door to competition in nuclear medicine.

All right.

Let's jump to clinical trial news.

Staying in oncology, we turn to radiopharmaceuticals.

On September 22nd, the FDA granted final generic approval to Lantheus' Bravnetza, a lutetium-177 dotatate, and rated it equivalent to Novartis' Lutathera,

And the rating is specific, bioequivalent and therapeutically equivalent.

The approval covers the same adults, those with somatostatin receptor-positive neuroendocrine tumors of the gut and pancreas.

Telex agreed to acquire ITM, a producer of medical isotopes that also owns ITM11, an investigational lutetium-177 infusion for neuroendocrine tumors of the gut and pancreas.

In its phase three compete trial, ITM11 improved progression-free survival over Everolimus.

That wasn't a comparison with Lutathera, and ETM11 is a separate program from Bravnetza.

For Telex, the deal is about what comes after imaging.

ITM 11 is an investigational radioactive drug given by infusion for neuroendocrine tumors of the gut and pancreas.

Novartis' Lutathera is already FDA-approved for somatostatin receptor positive tumors in that setting.

The pivotal compete trial compared the investigational drug with everolimus, not Lutathera.

The deal doesn't establish a clinical advantage over that incumbent.

ITM produces Lutetium-177 for therapeutic radiopharmaceuticals.

ITM adds scaled isotope production and an outside customer business.

If the deal closes and those relationships continue, Telix could supply an incumbent while developing its own challengers.

Pluvicto's prostate cancer market is distinct from the neuroendocrine setting for Lutathera and ITM 11.

Telex Pharmaceuticals and a company called ITM Isotope Technologies, based in Munich, are merging in a deal worth at least $1.65 billion, with more money on the table if things go well.

ITM's lead drug is a rival to Novartis' approved radiopharmaceutical Lutathera, which treats neuroendocrine tumors, a rare type of cancer.

This merger creates a second serious, well-funded competitor in a field that Novartis has basically owned since launching its own radioactive isotope therapies back in 2018 and 2022.

For rare cancer patients, more competition in this space could eventually mean more treatment options and, hopefully, downward pressure on pricing over time.

Now the company reports two-year kidney function results that address the question the FDA left open.

And Curium brings a new competitor to Lutathera, while GSK buys another development bet from Chimagen.

The clinical evidence and the commercial commitments tell different stories today.

Welcome to the Pharma Closeout for Tuesday, September fifteenth.

Curium's new radioligand entrant brings direct competition to an established neuroendocrine tumor treatment.

The company announced Bexlutri's FDA approval yesterday.

It references Novartis' Lutathera, and Curium describes it as the first radioligand equivalent.

The competitive question now extends beyond having another approved product to how it reaches the clinic.