Drug Approval | June 02, 2026
Bristol Myers Squibb wins EU approval for Opdivo-based frontline treatment in advanced hodgkin lymphoma
The approval is supported by results from the Phase 3 SWOG 1826 trial
The approval is supported by results from the Phase 3 SWOG 1826 trial
These approvals represent a defining moment for people living with classical Hodgkin Lymphoma
The FDA aims to make a decision by April 8, 2026
The approval was granted more than two months ahead of the Prescription Drug User Fee Act goal date
Recommendation based on results of Phase 3 CheckMate -9DW clinical trial demonstrating statistically significant and clinically meaningful improvement in overall survival with Opdivo plus Yervoy compared to investigator’s choice of lenvatinib or sorafenib in this patient population
Dual immunotherapy combination of Opdivo plus Yervoy demonstrated improved survival benefit compared to lenvatinib or sorafenib in this patient population
If approved, the Opdivo-based regimen would be the first immunotherapy-chemotherapy combination approved for this patient population in the EU
Opdivo-based treatments are now approved for five indications in upper gastroesophageal cancers
The approval marks the first-and-only immunotherapy-based treatment for use before surgery for non-small cell lung cancer
If approved, Opdivo plus chemotherapy would be the first neoadjuvant immunotherapy-based option for patients with resectable non-small cell lung cancer in the U.S.
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