Opdivo Approved for Advanced Head and Neck Cancer

The United States Food and Drug Administration (FDA) has approved the immunotherapeutic agent, Opdivo® (nivolumab) for the treatment of advanced head and neck cancer. Specifically,  the indication is for the treatment of squamous cell carcinoma of the head and neck cancer (SCCHN) that has spread to distant sites in the body and has progressed or recurred following prior therapy with a platinum-based chemotherapy agent.

Head and neck cancer refers to cancer that originates in areas of the head or neck, including the throat, voice box, mouth, salivary glands, lips, nasal cavity, and sinuses.  Squamous cells are the types of cells that line the moist surfaces of these locations, from which cancer may arise.

Opdivo is an agent that helps the immune system identify cancer cells, and mount an attack against them.  Opdivo is already approved for several different types of cancers, including certain types of lung cancer, melanoma, kidney cancer, and Hodgkin’s disease.

The latest approval for Opdivo in SCCHN was based on results from a clinical trial referred to as the Checkmate 141 trial.  It included 361 patients with SCCHN that had spread outside of the head or neck, or had progressed within 6 months of platinum-based chemotherapy.  Patients on the trial were divided into two treatment groups: one group was treated with nivolumab, and the second group was treated with standard therapy. The median time of overall survival was 7.5 months for patients treated with Opdivo, compared with 5.1 months for those treated with standard therapy.

Patients with advanced SCHHN whose cancer has progressed following prior therapy with cisplatin or carboplatin now have an additional treatment option for their disease.  Patients whose SCHHN has recurred may wish to speak with their physician regarding their individual risks and benefits of treatment with Opdivo.

Full prescribing information for Opdivo can be found at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125554s022lbl.pdf.

Reference: United States Food and Drug Administration (FDA).  Approved Drugs: Nivolumab for SCCHN. Available at: http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm528920.htm. Accessed November 21, 2016.

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