European regulators have agreed to review Bristol-Myers Squibb’s application to extend the current indications for cancer immunotherapy Opdivo to include the treatment classical Hodgkin lymphoma (cHL).
The firm is seeking approval for the drug to treat patients cHL after prior therapies, on the back of data from the CheckMate-205 trial assessing its use in relapsed or refractory forms of the illness, results from which are to be presented at a medical conference later this year.
“We are eager to continue to extend the use of Opdivo as a treatment option and potentially provide haematology with its first PD-1 inhibitor, a type of treatment that is designed to work with the PD-1 pathway and leverage the immune system to help fight classical Hodgkin lymphoma,” said Jean Viallet, oncology global clinical research lead at BMS.
“We are hopeful to build on expanding our haematology franchise and bring the science of Immuno-Oncology to these adult relapsed and refractory classical Hodgkin lymphoma patients in Europe who often have limited remaining treatment options.”
Opdivo (nivolumab) was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world in July 2014 and currently has regulatory approval in 48 countries, including the US, Japan and in the EU for non-small cell lung cancer, melanoma and kidney cancer.
Last week BMS announced plans to acquire all of the outstanding capital stock of Padlock, a private, Cambridge, Massachusetts-based biotechnology company dedicated to creating new medicines to treat destructive autoimmune diseases.
The acquisition will give BMS full rights to Padlock’s Protein/Peptidyl Arginine Deiminase (PAD) inhibitor discovery programme focused on the development of potentially transformational treatment approaches for patients with rheumatoid arthritis, with potential additional utility in treating systemic lupus erythematosus and other autoimmune diseases.