Topic is suspended
Status Suspended
Decision Selected
Process TAG
ID number 2693


Key events during the development of the guidance:

Date Update
09 March 2020 The Department for Health and Social Care has asked NICE to conduct an appraisal of avelumab for maintenance treatment of advanced gastric or gastro-oesophageal junction cancer after platinum-based chemotherapy [ID2693] The company have informed NICE that the phase III JAVELIN Gastric 100 study, evaluating the antibody in unresectable, locally advanced or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) cancer did not meet its primary endpoints of superior overall survival compared with standard of care, in either the overall intent-to-treat population or the PD-L1–positive population, despite the study showing clinical activity. As a result the company will not be filing for a Marketing Authorisation Application to the European Medicines Authority in this indication at this time. Therefore, NICE has decided to suspend this appraisal from its current work programme. As this appraisal has been referred NICE will continue to monitor any development and will update interested parties as and when the situation changes.
09 March 2020 Suspended. Topic is suspended

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