Celgene: Euro panel nod for combo in follicular lymphoma

REVLIMID^® and rituximab (R²) has the potential to become a chemotherapy-free combination treatment option for patients with follicular lymphoma who have relapsed or did not respond to previous treatment

The positive opinion was based on the results of the Phase 3 AUGMENT study, which showed the R² regimen conferred a statistically significantly improvement in progression-free survival versus rituximab monotherapy

Celgene Corporation (NASDAQ:CELG) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the approval of REVLIMID^® (lenalidomide) in combination with rituximab (anti-CD20 antibody) (R²) for the treatment of adult patients with previously treated follicular lymphoma (FL) (Grade 1-3a). If approved by the European Commission (EC), R² will be the first combination treatment regimen for patients with FL that does not include chemotherapy.

“Since its initial approval in 2007, REVLIMID has continued to demonstrate its benefits across a range of serious blood disorders in Europe and a CHMP positive opinion for this combination with rituximab is very good news for patients with follicular lymphoma. We look forward to the European Commission decision,” said Tuomo Pätsi, President of Hematology/Oncology for Celgene Worldwide Markets.

https://www.marketscreener.com/CELGENE-CORPORATION-8736/news/Celgene-Receives-CHMP-Positive-Opinion-for-REVLIMID-lenalidomide-in-Combination-With-Rituximab-29584583/