Here's some good news for patients with a tough diagnosis: the FDA just gave the okay for a new treatment option for Hodgkin lymphoma. The agency approved Bristol Myers Squibb & Co.'s (BMY) drug Opdivo, when used alongside a specific chemotherapy regimen, for people who haven't yet received treatment for their cancer.
The approval covers adults and kids 12 and older with previously untreated, Stage III or IV classical Hodgkin lymphoma (cHL). Hodgkin lymphoma is considered one of the more curable forms of cancer, especially when caught early, so new treatment options are always welcome. The specific combo is nivolumab (that's Opdivo) with the chemotherapy drugs doxorubicin, vinblastine, and dacarbazine, a regimen known as AVD.
In a bit of regulatory housekeeping, the FDA also granted what's called a "traditional approval" to Opdivo for use in adults whose Hodgkin lymphoma has come back or stopped responding to treatment. This covers patients after they've had an autologous stem cell transplant and treatment with brentuximab vedotin, or after three or more lines of therapy that included a transplant. Opdivo had received accelerated approvals for these uses back in 2016 and 2017, so this move essentially converts those to full, traditional approvals.
The new approval for untreated patients is backed by data from a study called CA209-8UT, which involved nearly 1,000 patients. The results were pretty compelling. The study showed that adding Opdivo to the AVD chemo significantly improved progression-free survival (PFS) compared to an older standard combo. The hazard ratio was 0.42, which is a statistical way of saying the risk of the disease getting worse was more than cut in half for patients on the Opdivo regimen.
After a median follow-up of about 14 months, the median PFS hadn't been reached in either treatment group, meaning many patients were still doing well. Looking further out, after a median follow-up of nearly three years, the data showed 1.8% of deaths in the Opdivo-plus-AVD group, compared to 3.4% in the group that got the older standard treatment.
Opdivo is a cornerstone product for Bristol Myers. It brought in a hefty $5.9 billion in revenue for the company in 2025. This latest approval adds another indication to its label. It's been a busy few weeks on the regulatory front for Bristol Myers; earlier in March, the FDA also approved the company's oral drug Sotyktu for treating adults with active psoriatic arthritis.
Despite the positive regulatory news, investors didn't seem to be celebrating. Bristol Myers Squibb shares were down 1.33% at $57.34 at the time of publication on Friday, according to market data.
