The FDA has approved Opdivo, along with doxorubicin, vinblastine, and dacarbazine (AVD) for adults and paediatric patients aged 12 years and above who have not previously been treated for Stage III or IV cHL.
In the European Union (EU), the EC granted approval for Opdivo in combination with brentuximab vedotin to treat children aged five years and above, adolescents, and adults up to 30 years who have relapsed or refractory cHL following one previous line of treatment.
The FDA approval is supported by data from the Phase III SWOG 1826 study, which assessed Opdivo plus AVD in adults and children aged 12 years or older.
A submission based on this trial is under review by the European Medicines Agency (EMA).
The EC approval is based on the Phase II CheckMate -744 trial, assessing Opdivo plus brentuximab vedotin in paediatric patients aged five years and above, adolescents and adults up to 30 years.
BMS oncology commercialisation senior vice-president Monica Shaw said: “These approvals represent a defining moment for people living with classical Hodgkin lymphoma. In the US, we are particularly proud that Opdivo in combination with AVD now stands as an immunotherapy combination available for adults and paediatric patients, ages 12 and older, with previously untreated advanced disease.
“Concurrently, in the EU, Opdivo in combination with brentuximab vedotin has also achieved a milestone as the first immunotherapy combination for certain relapsed or refractory patients. These milestones reflect our continued commitment to advancing science that meaningfully improves the lives of patients and families worldwide.”
Earlier this month, BMS received the FDA approval for Sotyktu (deucravacitinib), an oral selective tyrosine kinase 2 (TYK2) inhibitor, to treat adults with active psoriatic arthritis (PsA).