PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY) today announced that the European Commission (EC) has approved a new indication for Revlimid (lenalidomide), in combination with rituximab (anti-CD20 antibody), for the treatment of adult patients with previously treated follicular lymphoma (FL) (Grade 1-3a). This combination of Revlimid and rituximab (R2) is the first chemotherapy-free combination regimen approved for patients with FL by the EC.
FL is a subtype of indolent, but incurable, non-Hodgkin lymphoma (NHL) which is associated with immune system dysfunction. There remains an unmet medical need for novel treatments for patients who have relapsed or become refractory to their previous treatment. It has been hypothesized that the combination therapy, R2, works with the patient’s immune system using the immunomodulatory properties of Revlimid along with the CD20 antibody-targeted mechanism of action of rituximab in order to help the patient’s own immune system fight the cancer.
“This approval is a significant milestone for patients with follicular lymphoma whose disease is not responding to current therapy or has returned following prior treatment. In the phase 3 AUGMENT sudy, patients receiving R2 experienced extended periods of disease remission versus patients receiving rituximab plus placebo,” said Nadim Ahmed, President of Hematology at Bristol-Myers Squibb.
“Immune dysfunction is a defining aspect of indolent NHL, including follicular lymphoma,” said Prof. John Gribben, President of the European Hematology Association and Centre for Haemato-Oncology, Barts Cancer Institute, in England. “By utilizing the patient’s own immune system, R2 represents a new approach to treatment in follicular lymphoma, giving patients a chemotherapy-free option with demonstrated efficacy.”
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