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.