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The FDA has approved nivolumab (Opdivo, Bristol Myers Squibb) with doxorubicin, vinblastine, and dacarbazine (AVD) chemotherapy for the first-line treatment of patients aged 12 years and older with stage III or IV classic Hodgkin lymphoma.
The agency also granted traditional approval to nivolumab for the treatment of adults with relapsed or refractory classic Hodgkin lymphoma, either after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after three or more lines of systemic therapy that included autologous HSCT.
Nivolumab won accelerated approval for those indications in 2016 and 2017, respectively.
The new approval for nivolumab plus AVD, which followed priority review and orphan drug designation, was based on a progression-free survival benefit (hazard ratio, 0.42; P < .0001) demonstrated in the randomized, open-label Study CA209-8UT.
The trial randomized 994 patients 1:1 to receive either nivolumab plus AVD or brentuximab vedotin plus AVD for 6 cycles. After a median follow-up of 13.7 months, median progression-free survival was not reached in either arm. At a median follow-up of 36.7 months, 1.8% and 3.4% of patients in the nivolumab and control arms, respectively, had died.
Serious adverse reactions and immune-mediated adverse reactions occurred in 39% and 9%, respectively, of patients in the nivolumab plus AVD arm. Of the latter, 2.7% were grade 3 or 4 reactions.
The recommended dose of nivolumab is 240 mg for adults and children weighing at least 40 kg, or 3 mg/kg for children weighing less than 40 kg, administered intravenously with AVD on days 1 and 15 of each 28-day cycle, for up to six cycles. Primary granulocyte-colony stimulating factor prophylaxes is recommended beginning in the first cycle.
Full prescribing information will be posted on Drugs@FDA.
Sharon Worcester, MA, is an award-winning medical journalist based in Birmingham, Alabama, writing for Medscape, MDedge and other affiliate sites. She currently covers oncology, but she has also written on a variety of other medical specialties and healthcare topics. She can be reached at sworcester@mdedge.com or on X: @SW_MedReporter.
