A global clinical supply agreement between Telix Pharmaceuticals Limited and Eczacıbaşı-Monrol Nuclear Products Co. (Monrol) now includes (NCA) lutetium-177 (177Lu), a key therapeutic isotope used in Telix’s portfolio of Molecularly Targeted Radiation (MTR) products. The agreement expands an existing master services and distribution agreement concluded with Monrol in 2019 to support the ZIRCON Phase III trial of Telix’s TLX250-CDx (89Zr-DFO-girentuximab) investigational product for imaging of renal cell carcinoma with positron emission tomography (PET). Under the terms of the agreement, Monrol will supply 177Lu, for clinical and commercial use, in support of Telix’s drug development programs.
Telix expects to use Monrol 177Lu, both for the pending STARLITE Phase II (177Lu-DOTA-girentuximab for the treatment of metastatic renal cell carcinoma) and ProstACT Phase III (177Lu-DOTA-rosopatamab for the treatment of metastatic castrate-resistant prostate cancer) studies. Telix and Monrol will also validate the use of Monrol’s 177Lu production to support the commercial roll-out of Telix’s products in Monrol’s commercial territories, subject to completion of clinical studies and the relevant regulatory approvals.
Telix CEO Christian Behrenbruch stated, “Monrol is a leading nuclear medicine company in the countries in which it operates and has proven to be a reliable isotope supply, manufacturing, and distribution partner during the course of the ZIRCON study. We are pleased to expand our validated and trusted collaboration to include the supply of lutetium, an important radioisotope with broad utility in the treatment of human cancers.”
Monrol General Manager Aydın Küçük added, “Since we started collaborating with Telix in 2019, the Company has continued its rapid growth and is now recognized as a leading global company in the radiopharmaceutical field. We are very pleased to be working with Telix to supply 177Lu in support of Telix’s mission to help patients with cancer live longer, better quality lives.”Back To Top
Agreement Expands Alliance to Include Lutetium. Appl Radiol.