FDA Approves BMY's Opdivo Label Expansion in Classical Hodgkin Lymphoma

Bristol Myers Squibb BMY has strengthened its oncology franchise with new regulatory approvals for Opdivo (nivolumab) in classical Hodgkin lymphoma (cHL) across both the U.S. and European Union, reinforcing the drug’s expanding role in immunotherapy-led treatment paradigms.

Opdivo is a biologic and a fully human monoclonal antibody that binds to the PD-1 on T and NKT cells.

The FDA approved Opdivo in combination with doxorubicin, vinblastine and dacarbazine (AVD) for the treatment of adult and pediatric patients 12 years and older with previously untreated, stage III or IV cHL.

This marks the first immunotherapy-based regimen approved in the frontline setting for this population, positioning Opdivo as a potential new standard of care in advanced disease.

In the EU, the European Commission (EC) approved Opdivo in combination with brentuximab vedotin for select pediatric and young adult patients with relapsed or refractory cHL following prior therapy. This approval introduces the first immunotherapy combination option in this treatment setting, addressing a high unmet need.

We note that Opdivo is already indicated for the treatment of adult patients with cHL that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT. This indication was approved under accelerated approval based on overall response rate.

More on BMY’s Opdivo

The latest approval in the United States is backed by robust phase III SWOG 1826 data demonstrating a 58% reduction in disease progression or death and a meaningful improvement in progression-free survival versus standard regimens.

Meanwhile, the EC decision is supported by phase II CheckMate-744 results, validating efficacy in harder-to-treat relapsed populations.

These label expansions broaden Opdivo’s addressable market across both frontline and relapsed settings, enhance its competitive positioning in hematologic malignancies, and support long-term growth potential within Bristol Myers Squibb’s oncology portfolio.

Opdivo is approved for several oncology indications including bladder, blood, colorectal carcinoma (CRC), head and neck, renal cell carcinoma (RCC), hepatocellular carcinoma (HCC), lung, melanoma, malignant pleural mesothelioma (MPM), stomach and esophageal cancer.

The Opdivo+Yervoy regimen also is approved in multiple markets for the treatment of NSCLC, melanoma, MPM, RCC, CRC, HCC and various gastric and esophageal cancers.

Opdivo raked in sales of $10 billion in 2025.

BMY Looking to Diversify Portfolio Amid Legacy Drugs Decline

Bristol Myers delivered a resilient performance in 2025, supported by strong contributions from key growth drivers, such as Opdivo, Opdualag, Reblozyl, Breyanzi and Camzyos. These products helped stabilize the company’s revenue base despite ongoing generic erosion across its legacy portfolio.

Shares of the company have lost 5.8% in the past year against the industry’s growth of 9.1%.

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Blockbuster IO drug Opdivo, approved for several cancer indications, drives BMY’s oncology franchise along with Yervoy and Opdualag.

The FDA approval of Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) injection for subcutaneous use has boosted its IO franchise. Per BMY, this new subcutaneous formulation of Opdivo should help extend the reach and impact of its IO franchise to patients into the next decade.

Looking ahead, potential approvals of new drugs and label expansions for existing drugs should further diversify revenue streams.

BMY’s Zacks Rank & Key Picks

BMY currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks from the pharma/biotech sector are Liquidia Corporation LQDA, ADMA Biologics ADMA and ANI Pharmaceuticals ANIP . While LQDA and ADMA currently sport a Zacks Rank #1 (Strong Buy), ANIP carries a Zacks Rank #2 (Buy) each. You can see the complete list of today’s Zacks #1 Rank stocks here.

Over the past 60 days, estimates for LQDA’s earnings per share (EPS) have more than doubled to $1.75 in the past 30 days. Shares of LQDA have soared 65.9% over the past six months.

Over the past 60 days, estimates for ADMA’s 2026 EPS have increased from 85 cents to 96 cents. ADMA’s shares have lost 24.1% over the past year.

Over the past 60 days, estimates for ANI Pharmaceuticals’ EPS have increased from $8.28 to $8.99 for 2026. Over the past year, shares of ANIP have surged 13.1%.

ANI Pharmaceuticals' earnings beat estimates in each of the trailing four quarters, with the average surprise being 22.21%.

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