FDA approves nivolumab for recurrent or metastatic squamous cell carcinoma of the head and neck
On November 10, 2016, the U. S. Food and Drug Administration approved nivolumab (OPDIVO Injection, Bristol-Myers Squibb Company), for the treatment of 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 was based on data from an international, multi-center, open-label, randomized trial (CheckMate 141) comparing nivolumab with investigator’s choice (IC) of chemotherapy (either cetuximab, methotrexate, or docetaxel) in patients with recurrent or metastatic SCCHN with disease progression on or within 6 months of receiving platinum-based chemotherapy.
The trial enrolled 361 patients randomized (2:1) to nivolumab 3 mg/kg every 2 weeks intravenously (IV) (n=240) or IC (n=121) of either cetuximab 400 mg/m 2 IV once, then 250 mg/m2 IV weekly (n=15), methotrexate 40 mg/m2 IV weekly (n=52), or docetaxel 30 mg/m2 IV weekly (n=54) until disease progression or unacceptable toxicity.
The trial demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) associated with the nivolumab arm (Hazard Ratio 0.7 [95% CI: 0.52, 0.92]; p=0.0101, stratified log rank test). Estimated median OS was 7.5 months (95% CI=5.5, 9.1) in the nivolumab arm and 5.1 months (95% CI=4, 6.0) for IC.
Serious adverse reactions occurred in 49% of patients receiving nivolumab. The most frequent serious adverse reactions reported in at least 2% of patients receiving nivolumab were pneumonia, dyspnea, respiratory failure, respiratory tract infection, and sepsis. The most common adverse reactions occurring in more than 10% of nivolumab-treated patients and at a higher incidence than IC were cough and dyspnea. The most common laboratory abnormalities occurring in 10% or more nivolumab-treated patients and at a higher incidence than IC were increased alkaline phosphatase, increased amylase, hypercalcemia, hyperkalemia, and increased TSH.
The recommended dose and schedule for nivolumab for SCCHN is 3 mg/kg IV every two weeks.
Full prescribing information is available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125554s022lbl.pdf
Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System by completing a form online at http://www.fda.gov/medwatch/report.htm, by faxing (1-800-FDA-0178) or mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).
