FDA OKs Opdivo+AVD for Hodgkin Lymphoma, EMA Approval Boosts $361m Forecast
FDA approved Opdivo with AVD as first-line therapy for stage III–IV Hodgkin lymphoma in patients aged 12+, marking the first US anti-PD-1 approval for frontline HL. EMA cleared Opdivo combined with brentuximab vedotin for relapsed or refractory HL in patients aged 5–30, driving forecasted global sales to $361m by 2028.
1. FDA Approval for First-Line Hodgkin Lymphoma
On 20 March FDA expanded Opdivo’s label to include combination with AVD chemotherapy as first-line treatment for stage III–IV Hodgkin lymphoma in patients aged 12 and older, making it the first anti-PD-1 therapy approved for frontline HL in the US.
2. EMA Approval in Relapsed and Refractory HL
The EMA approved Opdivo in combination with brentuximab vedotin for patients aged 5–30 with relapsed or refractory Hodgkin lymphoma, offering clinicians an additional immunotherapy option in Europe.
3. SWOG 1826 Trial Demonstrates Superior PFS
Phase III SWOG 1826 showed Opdivo+AVD improved progression-free survival by 56% over brentuximab+AVD at a median 36.7-month follow-up, with lower discontinuation rates (7.6% vs 12%) and fewer deaths (1.8% vs 3.4%), despite higher grade ≥3 neutropenia.
4. Projected Sales Growth and Market Impact
Global Opdivo sales, which totaled $288m in 2024, are projected to reach $361m by 2028 at a 5.81% CAGR, displacing brentuximab vedotin’s market share by 2.89%, with European sales expected to grow at a 10.53% annual rate.