FDA Approves Nivolumab Plus Chemotherapy as First-Line Treatment for Hodgkin Lymphoma

The Food and Drug Administration (FDA) has approved the combination of nivolumab and chemotherapy as a first-line treatment option for certain patients with stage III or IV classical Hodgkin lymphoma. This approval applies to individuals aged 12 years and older.

Improved Progression-Free Survival

The approval is based on data from a randomized clinical trial demonstrating that nivolumab (Opdivo, Bristol Myers Squibb) in combination with doxorubicin, vinblastine, and dacarbazine (AVD) significantly improved progression-free survival (PFS) by 58% compared to brentuximab vedotin (Adcetris, Seagen) plus AVD.

Trial Results

The phase 3 SWOG S1826 trial, which included 994 patients, showed a significantly reduced risk of progression or death in the nivolumab arm (HR = 0.42; 95% CI, 0.27-0.67) after a median follow-up of 13.7 months. After a longer median follow-up of 36.7 months, fewer deaths occurred in the nivolumab arm (1.8% vs. 3.4%).

Safety Profile

Serious adverse reactions were reported in 39% of patients receiving nivolumab, and immune-mediated adverse events occurred in 9% of patients (with 2.7% experiencing grade 3-4 events).

Dosage and Administration

The FDA-recommended dose for intravenous nivolumab in this patient population is 240 mg for patients weighing at least 40 kg, and 3 mg/kg for those weighing less than 40 kg. Treatment should be administered on days 1 and 15 of 28-day cycles for up to six cycles.

Expanded Approvals

The FDA has also granted traditional approval for nivolumab for patients following autologous hematopoietic stem cell transplant and brentuximab vedotin, as well as after three or more lines of systemic therapy, including at least one stem cell transplant. These indications previously had accelerated approval.

Source: Healio