Bristol-Myers Squibb’s immunotherapy Opdivo has taken a step towards the US market for classical Hodgkin lymphoma (cHL) after regulators accepted an application for its use in pre-treated patients.
The application includes data from the Phase II CheckMate-205 trial, which assessed Opdivo (nivolumab) in cHL patients who have received autologous stem cell transplant and brentuximab vedotin. Data from the trial are expected to be presented at a medical meeting later this year, the firm noted.
“There is a significant burden on classical Hodgkin lymphoma patients who do not respond to initial treatment, and they need new treatment options that address the disease in a different way,” said Jean Viallet, Oncology Global clinical research lead at BMS. “With the Agency’s acceptance of our application, Opdivo has the potential to be the first PD-1 inhibitor in haematology”.
Opdivo 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 various indications in non-small cell lung cancer, melanoma and kidney cancer.
The drug was approved by the European Commission this week for locally advanced or metastatic non-squamous non-small cell lung cancer and kidney cancer, while an application for its use in cHL is also under review.