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FDA grants accelerated approval to Opdivo for classical Hodgkin lymphoma
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The FDA today granted accelerated approval to nivolumab for treatment of certain patients with classical Hodgkin lymphoma.
Nivolumab (Opdivo, Bristol-Myers Squibb) is indicated for patients who relapsed or progressed after autologous hematopoietic stem cell transplant (HSCT) and posttransplant brentuximab vedotin (Adcetris, Seattle Genetics).
The agency recommended a dose schedule of 3 mg/kg nivolumab via IV every 2 weeks until disease progression or unacceptable toxicity.
The FDA based the approval in part on results of two single-arm, multicenter trials that evaluated nivolumab in this patient population, regardless of PD-L1 expression.
Objective response rate served as the primary endpoint. Duration of response served as a secondary outcome measure.
Efficacy analyses included 95 patients who had undergone a median five prior systemic regimens (range, 3-15) and received a median 17 doses (range, 3-48) of nivolumab.
Researchers reported a 65% (95% CI, 55-75) objective response rate; 58% of patients achieved partial remission and 7% achieved complete remission.
Median time to response was 2.1 months, and estimated median duration of response was 8.7 months.
Safety analyses included 263 patients, 98% of whom had undergone autologous HSCT. These patients received a median 10 doses (range, 1-48) of nivolumab.
Adverse reactions reported in at least 20% of the patient population included fatigue, upper respiratory tract infection, cough, pyrexia and diarrhea. Other adverse reactions reported in at least 10% of patients included rash, pruritus, musculoskeletal pain, nausea, vomiting, abdominal pain, headache, peripheral neuropathy, arthralgia, dyspnea, infusion-related reactions and hypothyroidism or thyroiditis.
Twenty-one percent of patients experienced serious adverse reactions, the most common of which were pneumonia, pleural effusion, pneumonitis, pyrexia, infusion-related reaction and rash.
A new “warning and precaution” label was issued for complications of allogeneic HSCT after nivolumab. The label urges health care professionals to follow patients closely for early evidence of transplant-related complications, including hyperacute graft-versus-host disease, severe acute GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease and other immune-mediated adverse reactions.
The FDA has required Bristol-Myers Squibb to further evaluate the safety of allogeneic HSCT after nivolumab.