Bristol Myers Squibb transforms lymphoma treatment paradigm with expanded approvals for Opdivo

Bristol Myers Squibb has recently announced that Opdivo has received approval for two new classical Hodgkin Lymphoma indications in the U.S. and the EU. The U.S. FDA granted approval of Opdivo in combination with doxorubicin, vinblastine and dacarbazine for the treatment of adult and pediatric patients 12 years and older with previously untreated, Stage III or IV cHL.

“These approvals represent a defining moment for people living with classical Hodgkin Lymphoma,” said Monica Shaw, MD, Senior Vice President of Oncology Commercialization. “In the U.S., we are particularly proud that Opdivo in combination with AVD now stands as an immunotherapy combination available for adults and pediatric patients, ages 12 and older, with previously untreated advanced disease.¹ 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.² These milestones reflect our continued commitment to advancing science that meaningfully improves the lives of patients and families worldwide.”

Note that the U.S. approval is based on the Phase 3 SWOG 1826 study, evaluating Opdivo in combination with AVD for adult and pediatric patients with previously untreated Stage III or IV cHL. A submission based on SWOG 1826 study is also currently under evaluation by the EMA.

In addition, the EU approval is based on the Phase 2 CheckMate -744 study, evaluating Opdivo in combination with brentuximab vedotin for the treatment of children 5 years of age and older, adolescents and adults up to 30 years of age with relapsed or refractory cHL after one prior line of therapy.

“For decades, treatment approaches in classical Hodgkin Lymphoma have presented significant challenges, both for newly diagnosed patients and those facing relapse,”^5,6 said Alex Herrera, M.D., Chief of Division of Lymphoma, Department of Hematology & Hematopoietic Cell Transplantation, City of Hope National Medical Center. “In the U.S., the nivolumab-based combination for patients with previously untreated Stage III or IV cHL demonstrated improved progression-free survival compared with standard of care, BV-AVD. The SWOG 1826 study provides data for frontline use of this immunotherapy-based regimen.”

“The availability of another treatment option for people living with certain types of Hodgkin lymphoma can make a real difference,” says Gwen Nichols, M.D., Chief Medical Officer of Blood Cancer United. “Each new FDA-approved therapy brings renewed hope for patients and their families, and advances like this one signal meaningful progress in improving outcomes for people facing this disease.”

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Related Topics and Keywords

Adjuvant Opdivo, Bristol-Myers Squibb (BMS), lymphoma, Opdivo