This approval represents the first regulatory approval for Celgene in Switzerland, and Revlimid represents the first oral therapy in Switzerland for multiple myeloma patients in more than 40 years, according to the company.
Both the FDA and the EMEA have approved Revlimid in combination with dexamethasone for the treatment of multiple myeloma patients who have received at least one prior therapy.
Celgene International says it is working diligently with Swissmedic to determine the next steps for pricing, reimbursement and distribution so that the drug is available for eligible patients in Switzerland as quickly as possible.
The marketing authorization application for the drug was based upon the safety and efficacy results of two large, randomized pivotal Phase III special protocol assessment trials evaluating Revlimid plus dexamethasone in multiple myeloma patients that have received at least one prior therapy.