Early access to medicines scheme (EAMS) scientific opinion: Nivolumab for treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal cancer after prior chemotherapy

The positive EAMS opinion is based on a Phase III study (n=419), in which nivolumab was associated with an improvement in overall survival as compared with investigator’s choice taxane chemotherapy (median 10.9 v 8.4 months; HR 0.77; 95% CI 0.62-0.96; p=0.0189).

SPS commentary:

There is currently no licensed treatment for oesophageal cancer at this stage of the disease and patients are offered palliative therapy to ease their symptoms. The scientific opinion includes a public assessment report; a treatment protocol (for healthcare professionals and for patients); information on the pharmacovigilance system; and background information for NHS Medical Directors.


Medicines and Healthcare products Regulatory Agency