Betalutin™ is the brand name of an anti-CD37 antibody labeled with 177Lu, known under the names 177Lu-Lilotomab satetraxetan (official INN since January 2015) or 177Lu-DOTA-HH1. Lilotomab (HH1) is a murine monoclonal antibody developed at the Norwegian Radium Hospital. In 2014, the drug has received Orphan Drug status for Follicular Lymphoma in the USA and the EU.
Lilotomab binds to the glycoprotein CD37 on the surface of mature malignant and non-malignant human B cells and can therefore be used as a tumor-targeting carrier for radioactive and cytotoxic payloads for the treatment of hematological cancer. 177Lu-Betalutin is currently being tested in patients with relapsed or refractory low-grade non-Hodgkin’s lymphoma.
177Lu-Betalutin is going through Phase I/II clinical trials for the treatment of relapsed NHL targeting patients with relapsed CD37 positive non-Hodgkin’s lymphoma. First results of LYMRIT-37-01 published in June 2017 confirmed promising efficacy and safety profile. Launch is expected by 2024.
A new study in patients with Follicular Lymphoma was initiated in October 2018.
A Phase I study in patients with Diffuse Large B Cell Lymphoma is now also on-going with final dosing regimen (20 MBq/kg for Betalutin and 100 mg/m² for Lilotomab).