The Food and Drug Administration (FDA) has approved a new indication for Opdivo (nivolumab injection; Bristol-Myers Squibb), a programmed death receptor-1 (PD-1) blocking antibody. Opdivo is now approved to treat patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after a platinum-based therapy.

Approval of the new indication was based on data from the CheckMate 141 trial which included 361 patients.  The study compared nivolumab 3mg/kg every 2 weeks intravenously (IV) with investigator’s choice (IC) of chemotherapy (cetuximab 400mg/m2 IV once, then 250mg/m2 IV weekly [n=15], methotrexate 40mg/m2 IV weekly [n=52], or docetaxel 30mg/m2 IV weekly [n=54]) in patients with recurrent or metastatic SCCHN with disease progression on or within 6 months of receiving platinum-based chemotherapy.

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A statistically significant and clinically meaningful improvement in overall survival (OS) was noted with the nivolumab arm (Hazard Ratio 0.7 [95% CI: 0.52, 0.92]; p=0.0101, stratified log rank test). Compared to 5.1 months (95% CI=4, 6.0) in the IC arm, the estimated median OS was 7.5 months (95% CI=5.5, 9.1) in the nivolumab group.

Cough and dyspnea were the most common adverse reaction occurring in >10% of nivolumab-treated patients and at a higher incidence than patients given IC.

In addition to this new indication, Opdivo is also approved for: advanced renal cell carcinoma in patients who have received prior anti-angiogenic therapy; classical Hodgkin lymphoma that relapsed or progressed after autologous hematopoietic stem cell transplantation and post-transplantation brentuximab vedotin; as a single agent for patients with BRAF V600 wild-type or BRAF V600 mutation (+) unresectable or metastatic melanoma; in combination with ipilimumab for unresectable or metastatic melanoma; and metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.

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