Opdivo Gains New Indication
November 10, 2016 – The US FDA approved a new indication for Opdivo® (nivolumab), manufactured by Bristol-Myers Squibb. Opdivo is a programmed death receptor-1 (PD-1) checkpoint inhibitor. The monoclonal antibody was approved to treat patients who have squamous cell carcinoma of the head and neck (SCCHN) that has spread or come back despite prior or concurrent treatment with a platinum-based chemotherapy drug. As an immunotherapy agent, it enhances the ability of the immune system to attack and destroy cancer cells. In the clinical trial, CheckMate-14, the average overall survival rate was about 7.5 months for Opdivo-treated patients compared to about 5.1 months for patients treated with other standard drugs. For SCCHN, Opdivo is given once every two weeks through a 60-minute IV infusion that contains 3mg of drug for each Kg the patient weighs. Originally FDA approved Opdivo in December 2014 as a breakthrough therapy for advanced melanoma; it also has several additional indications, both alone and in combination with other drugs, to treat various types of cancer.
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