publication date: Nov. 11, 2016

Drugs and Targets FDA Approves BMS’s Opdivo for  Head and Neck Cancer Indication            

OPDIVO (nivolumab) received FDA approval for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after a platinum-based therapy.

The drug is sponsored by Bristol-Myers Squibb C.

Approval was based on data from an international, multi-center, open-label, randomized trial (CheckMate 141) comparing nivolumab with investigator’s choice 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/m2 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 … Continue reading FDA Approves BMS’s Opdivo for Head and Neck Cancer Indication

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