Opdivo Gets US Breakthrough Status

US regulators have given a breakthrough designation to Bristol-Myers Squibb’s cancer drug Opdivo (nivolumab) for treating head and neck cancer. This is the fifth breakthrough designation for Opdivo from the US Food and Drug Administration (FDA) and follows that issued for classical Hodgkin lymphoma earlier this month.

European regulators also this month expanded Opdivo’s indications for treating patients with lung and kidney cancer. The move has been spurred by early clinical evidence which showed that the treatment could significantly improve the survival rates of patients suffering with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) who have already undergone platinum-based therapy.

Data from a Phase 3 trial indicated that patients taking Opdivo saw a 30% reduction in the risk of death compared with the standard therapies of methotrexate, docetaxel or cetuximab. Head and neck cancer is the second most common cancer in the world with an estimated 400,000 to 600,000 new cases and 223,000 to 300,000 deaths every year.

Opdivo is already available in the US to treat certain forms of melanoma, non-small cell lung cancer and kidney cancer.