The establishment of radiopharmacy in National Medical Radiological Centre

A lot of radiopharmaceuticals for radionuclide diagnostics and therapy of a large number of diseases, mainly cancer, have been developed in Russia. However, a significant part of them are not registered in Russia. It makes them unavailable for patients with terminal stages of malignant neoplasms. In 2020 the Russian Ministry of Health issued Orders No. 1218n (12.11.2020) and No. 780n (31.07.2020), which provided wide opportunities for medical organizations to manufacture radiopharmaceuticals, including those, which are not registered in the Russian Federation. In 2021, a radiopharmacy (nuclear pharmacy) was organized in A. Tsyb Medical Radiological Research Centre – a branch of Federal State Budgetary Institution «National Medical Radiological Centre» of the Ministry of Health of the Russian Federation. To date, the following therapeutic radiopharmaceuticals are manufactured in radiopharmacy: 1) «Lutaprost-MRRC» - radiopharmaceutical radiopharmaceutical based on low molecular weight PSMA inhibitor (PSMA-617) and lutetium-177 for radioligand therapy of patients with metastatic castrate-resistant prostate cancer; 2) «Prostactin-MRRC» - radiopharmaceutical based on PSMA-617 and alpha-emitting radionuclide actinium-225 for radioligand therapy of patients with metastatic castrate-resistant prostate cancer; 3) «Hepatoren-MRRC» - radiopharmaceutical based on human blood albumin microspheres (20-40 μm in diameter), labeled with rhenium-188, for hepatic artery radioembolization and inoperable liver cancer treatment; 4) «Artroren-MRRC» - radiopharmaceutical based on human blood albumin microspheres (5-10 μm in diameter), labeled with rhenium-188, for radiosynovectomy of knee joints with synovitis; 5) 177Lu-DOTATATE - radiopharmaceutical based on octreotide analog and lutetium-177 for radioligand therapy of patients with neuroendocrine tumors. The radiopharmacy has all authorization documents for working with radioactive substances and for manufacturing radiopharmaceuticals for the needs of the medical organization. These radiopharmaceuticals are not registered in Russia, but the possibility of their manufacturing makes them available for treatment patients in Russia.