On 20 March, Bristol Myers Squibb (BMS) announced that the FDA granted approval for Opdivo (nivolumab), an immune checkpoint inhibitor in combination with adriamycin, vinblastine, and dacarbazine (AVD) chemotherapy, as a first-line treatment for stage III–IV chemotherapy in patients aged 12 years and older with Hodgkin lymphoma (HL). This landmark approval makes Opdivo the first anti-PD-1 immunotherapy to be officially approved for the first-line treatment of HL in the US. In the same week, Opdivo was also approved by the EMA for use in combination with Pfizer’s antibody-drug conjugate Adcetris (brentuximab vedotin) in relapsed and refractory HL patients aged 5–30 years. These landmark approvals offer clinicians valuable additional options for treating patients as current treatments may be inaccessible or ineffective.
These approvals have followed the completion of two key clinical trials. The Phase III SWOG 1826 trial has been completed in the US, and in Europe, the Phase II CheckMate-744 trial was completed at the end of 2024. The SWOG 1826 trial compared Adcetris in combination with AVD against Opdivo plus AVD, and assessed the progression-free survival (PFS) of stage III–IV HL patients who were treated in primary care. Updated efficacy data from the SWOG 1826 trial was reported at the American Society of Hematology (ASH) Annual Meeting in December 2025. In the trial, the Opdivo regimen demonstrated superiority over the Adcetris regimen, with a median 36.7-month follow-up, with a 56% improvement in the incidence of PFS. Grade ≥3 adverse events were more frequent in the Opdivo plus AVD group, mostly derived from neutropenia, although the regimen also had lower discontinuation rates (7.6% versus 12%, respectively), and fewer deaths (1.8% versus 3.4%). Based on these results, the FDA expedited the approval of the expanded drug labelling, and guidelines have now been updated to replace Adcetris as the preferred treatment for this patient subgroup.
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These approvals will incite a modest reorganisation in the market of antibody-based therapies for HL. In 2024, Adcetris earned over $1.2bn globally, while Opdivo had sales of $288m. With the expansion of Opdivo in the treatment paradigm, its sales are expected to grow globally to $361m by 2028 at a compound annual growth rate (CAGR) of 5.81%. Opdivo will displace some use of Adcetris, causing a market withdrawal of -2.89%, according to a GlobalData analyst consensus forecast. The EMA’s approval of Opdivo offers a particular stimulus in Europe, contributing to the forecast growth of European sales at a CAGR of 10.53% through 2028.
This is an important lead for BMS, as other anti-PD-1 drugs are gaining traction for use in HL, such as MSD’s Keytruda (pembrolizumab), which had global sales of $123 million in 2024 for HL. Keytruda has also reported favourable efficacy and safety profiles for relapsed or refractory HL patients. GlobalData forecasts that Keytruda’s sales for HL will grow at a more modest CAGR of 2.92% through 2028, as it falls behind Opdivo as the immune checkpoint inhibitor of choice for HL.
The growing landscape of innovative HL therapies will interest patients and clinicians, as they will benefit from having more treatment options in this otherwise highly limited space.
