Bristol Myers Squibb Expands Opdivo Use After Trial Shows 58% Risk Cut

Edgen Stock·Mar 20 2026, 21:09

Share to

Share to

Copy link

Key Takeaways

Bristol Myers Squibb (NYSE: BMY) has secured expanded approvals for its blockbuster cancer drug Opdivo from both U.S. and European regulators for treating classical Hodgkin Lymphoma (cHL). The approvals expand Opdivo's addressable market and strengthen the company's oncology franchise ahead of key patent expirations.

Dual Regulatory Wins: The U.S. FDA and European Commission approved new Opdivo-based combination therapies for different patient groups with classical Hodgkin Lymphoma.
Strong Clinical Data: The U.S. approval was supported by a Phase 3 trial showing the Opdivo regimen reduced the risk of disease progression or death by 58% compared to a standard of care.
Strategic Importance: These approvals are critical for bolstering Bristol Myers' revenue pipeline as it prepares for the loss of patent exclusivity on top-selling drugs Opdivo and Eliquis in 2028.

Opdivo Regimen Shows 58% Lower Progression Risk, Securing FDA Approval

Bristol Myers Squibb (NYSE: BMY) announced on March 20, 2026, that it received two significant regulatory approvals for its immunotherapy drug, Opdivo (nivolumab). The U.S. Food and Drug Administration (FDA) approved Opdivo combined with chemotherapy (AVD) for previously untreated, Stage III or IV classical Hodgkin Lymphoma (cHL) in patients aged 12 and older. This decision was based on the pivotal Phase 3 SWOG 1826 study, which demonstrated a statistically significant 58% reduction in the risk of disease progression or death.

Simultaneously, the European Commission (EC) approved Opdivo in combination with brentuximab vedotin to treat relapsed or refractory cHL in children, adolescents, and young adults from 5 to 30 years old. This approval, based on the Phase 2 CheckMate -744 study, establishes the first immunotherapy combination for this specific patient population in the EU. These approvals widen the treatment paradigm for a cancer that is the most common type diagnosed in adolescents.

Approvals Bolster Growth Portfolio Ahead of 2028 Patent Cliff

These dual approvals are a critical component of Bristol Myers Squibb's strategy to offset a looming revenue challenge. The company faces a "patent cliff" in 2028, when its two highest-grossing drugs, the blood thinner Eliquis and Opdivo itself, lose patent exclusivity. Expanding the approved uses for Opdivo maximizes its revenue potential and reinforces the company's dominant position in the oncology market before generic competition emerges.

The new indications directly contribute to BMY's designated "growth portfolio," a collection of newer drugs designed to drive future sales. This portfolio accounted for approximately 55% of total revenue in 2025, up from 47% the prior year, signaling progress in the company's lifecycle management. For investors, these approvals demonstrate BMY's ability to execute on its pipeline and extend the commercial life of its key assets.