Bristol Myers Squibb’s (BMS) Opdivo (nivolumab) has been approved for two new classical Hodgkin lymphoma (cHL) indications in the US and the EU.
The US FDA has approved Opdivo in combination with doxorubicin, vinblastine and dacarbazine (AVD) to treat patients 12 years and older with previously untreated stage 3 or 4 cHL.
In the EU, approval has been granted by the European Commission (EC) for Opdivo in combination with brentuximab vedotin to treat patients between five and 30 years of age with relapsed or refractory cHL who have already received one prior line of therapy.
SWOG 1826, a phase 3 study on which the US FDA based its approval, evaluated Opdivo in combination with AVD in patients aged 12 years and older with previously untreated stage 3 or 4 cHL.
The study showed a 58% reduction in the risk of disease progression or death, showing a statistically significant improvement in the primary endpoint of progression-free survival (PFS) for patients who received Opdivo in combination with AVD.
Results from the SWOG 1826 trial have also been included in a submission to the European Medicines Agency (EMA).
EU approval was based on the open-label phase 2 CheckMate -744 study evaluating the safety and efficacy of nivolumab plus brentuximab vedotin.
Hodgkin lymphoma (HL), also known as Hodgkin disease, is a cancer that starts in white blood cells called lymphocytes, which are part of the body’s immune system.
Classical Hodgkin lymphoma is the most common type, accounting for 95% of cases.
HL is the most common cancer diagnosed in teenagers aged 15 to 19. It is most often diagnosed in patients aged 20 to 39 and also in older patients over the age of 55.
Despite progress in frontline therapy, advanced-stage HL still carries a substantial risk of relapse, highlighting the need for innovative approaches.