The U.S. Food and Drug Administration (FDA) on Friday approved Bristol Myers Squibb & Co.’s (NYSE:BMY) Opdivo (nivolumab) with chemotherapy for untreated Hodgkin lymphoma, one of the most curable forms of cancer, with high long-term survival rates, particularly when detected early.

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Hodgkin lymphoma (HL) is a cancer in which multinucleated Reed–Sternberg cells (RS cells) are present in the lymph nodes.

The approval covers nivolumab with doxorubicin, vinblastine and dacarbazine (AVD) for adult and pediatric patients 12 years and older with previously untreated, Stage III or IV classical Hodgkin lymphoma (cHL). The FDA also granted traditional approval to nivolumab for the following indications in adults with relapsed or refractory cHL after:

  • Autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin.
  • Three or more lines of systemic therapy that include autologous HSCT.

Nivolumab received accelerated approval for these indications in 2016 and 2017, respectively.

Bristol Myers Efficacy and Safety

Efficacy of nivolumab in combination with AVD was evaluated in Study CA209-8UT. A total of 994 patients were randomized.

The study demonstrated superiority of progression-free survival (PFS) in the nivolumab plus AVD arm, with a hazard ratio of 0.42.

The median PFS was not reached in either arm, after a median follow-up of 13.7 months.

After a median follow-up of 36.7 months, there were 1.8% deaths in the nivolumab plus AVD arm and 3.4% in the brentuximab vedotin plus AVD arm.

In 2025, Opdivo generated revenues of $5.9 billion.

Earlier in March, the FDA approved Bristol Myers’ oral drug Sotyktu to treat adults with active psoriatic arthritis.

BMY Stock Price Activity: Bristol Myers Squibb shares were down 1.33% at $57.34 at the time of publication on Friday, according to Benzinga Pro data.

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