To appraise the clinical and cost effectiveness of Lenalidomide in combination with R-CHOP chemotherapy within its marketing authorisation for Diffuse Large B-cell Lymphoma
Referred 18 March 2019
Status Suspended
Decision Selected
Process STA 2018
ID number 1611


Key events during the development of the guidance:

Date Update
19 September 2019 Suspended. Referred 18 March 2019
19 September 2019 The company have informed NICE that the phase III ROBUST trial evaluating REVLIMID plus rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) chemotherapy (R2-CHOP) in patients with previously untreated activated B-cell (ABC) subtype diffuse large B-cell lymphoma (DLBCL) did not meet the primary endpoint of demonstrating superiority in progression-free survival (PFS) compared to placebo plus R-CHOP. 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 if the situation changes.
08 May 2019 In progress. Referred 18 March 2019

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