EpiCept Corporation has been granted a full marketing authorisation by the European Commission for Ceplene(R) for the remission maintenance and prevention of relapse in adult patients with Acute Myeloid Leukaemia (AML) in first remission.
The approval allows Ceplene to be marketed in the 27 member states of the European Union and is to be administered in conjunction with low-dose interleukin-2 (IL-2).
Jack Talley, president and CEO of EpiCept, “Today marks a significant and welcome milestone for patients suffering from AML. Ceplene is now the first approved therapy demonstrated to produce a clear benefit in prolonging leukemia-free survival and preventing relapse among AML patients. We are proud that this new therapeutic option will be available to physicians and patients in 30 countries.”
In part, the approval by the European Commission is based on the results of the pivotal 320-patient phase III trial for Ceplene in conjunction with IL-2. The primary result of this trial was that treatment with Ceplene/IL-2 significantly reduced the occurrence of relapse among AML patients in complete remission. The improvement of long-term leukemia-free survival in patients receiving Ceplene/IL-2 exceeded 50%.
“The main challenge in AML treatment is to protect patients in their first complete remission from relapse, as a first relapse is associated with poor long-term survival. The combination of Ceplene and IL-2 has been demonstrated to be a safe therapy that improves leukemia-free survival by significantly reducing the risk of recurrent leukemia. Therefore, the approval granted for Ceplene is an important step forward in making the treatment available to AML patients,” said Mats Brune, M.D., associate professor at Sahlgrenska University and principal investigator of the Ceplene phase III clinical trial.