Credit: CDC
Swissmedic, the regulatory authority for Switzerland, has granted
approval for lenalidomide (Revlimid) to treat patients with
relapsed or refractory mantle cell lymphoma (MCL) after prior therapy
that included bortezomib and chemotherapy or rituximab.
This is the third approval of lenalidomide for MCL worldwide. The drug is also approved for this indication in the US and Israel.
Swissmedic’s decision to approve the drug was based on results of the phase 2 EMERGE study (MCL-001).
In this trial, researchers evaluated lenalidomide (25 mg once a day on days 1-21 of each 28-day cycle) in 134 MCL patients who had received prior treatment with rituximab, cyclophosphamide, an anthracycline (or mitoxantrone), and bortezomib alone or in combination.
The overall response rate (the primary endpoint) was 28% (37/134), and the complete response rate was 7% (10/134). The median duration of response was 16.6 months (95% CI, 7.7-26.7).
The most common grade 3/4 adverse events reported in at least 5% of patients were neutropenia (43%), thrombocytopenia (28%), anemia (11%), pneumonia (9%), fatigue (7%), leukopenia (7%), febrile neutropenia (6%), diarrhea (6%), and dyspnea (6%).
“MCL is a rare B-cell lymphoma of the elderly that usually responds quite well to first-line treatment,” said Christoph Renner, MD, of Onkozentrum Hirslanden Zürich.
“However, even intensive treatment does not prevent relapse in the majority of patients, and new therapeutic options are needed. Therefore, having access to lenalidomide, an immunomodulatory drug with a well-known safety profile, will definitely enrich our therapeutic armamentarium.”
Lenalidomide is already approved in Switzerland for use in combination
with dexamethasone to treat patients with multiple myeloma who have
received at least one previous treatment.
The drug is also
approved to treat patients with transfusion-dependent anemia due to low-
or intermediate-risk-1 myelodysplastic syndrome associated with a 5q
deletion, with or without additional cytogenetic abnormalities.
Lenalidomide is under development by Celgene International Sàrl, a wholly owned subsidiary of Celgene Corporation.
