Celgene Corp. (CELG) secured approval from the Food And Drug Administration (FDA) to expand the use of Revlimid (lenalidomide) 10-mg capsule version. The approval will enable the drug to be used as a maintenance therapy for patients with multiple myeloma following autologous hematopoietic stem cell transplant (auto-HSCT). (See also, Celgene Buys Blood Cancer Drug Maker Acetylon.)

Revlimid as Maintenance Therapy

A drug is classified as maintenance therapy if it supports a primary treatment leading to its success and increased effectiveness. For instance, while treating cancer, a maintenance chemotherapy may be administered to stop a recurrence of the disease.

HSCT involves the intravenous infusion of certain stem cells to restore the necessary function in patients whose bone marrow or immune system is damaged. The transplant-eligible multiple myeloma patients are prone to disease recurrence or progress after the necessary therapy.

Revlimid maintenance therapy can be an efficient treatment option as a maintenance therapy for such patients, as it has demonstrated increased progression free survival (PFS) following autologous stem cell transplant in clinical trials, says Dr. Philip McCarthy, Director, Blood and Marrow Transplant Center, Department of Medicine at Roswell Park Cancer Institute. PFS is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.

Positive Trial Results

The recent label expansion was approved based on the results achieved in two separate trials. The comparative trials assessed Revlimid maintenance therapy that was administered until disease progression or unacceptable toxicity after auto-HSCT against no maintenance. In both the trials, Revlimid maintenance achieved the desired primary endpoint of PFS.

Revlimid was first approved in June 2006 in combination with dexamethasone for treating patients with multiple myeloma who have received at least one earlier therapy. The drug secured expansion in February 2015 to include treatment of patients with newly diagnosed multiple myeloma (NDMM).

The drug has also secured positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for the maintenance treatment of adult NDMM patients who have undergone autologous stem cell transplantation. (See also, Celgene MS Drug Reports Positive Phase 3 Data.)

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