EU expands use of Revlimid to include post ACST use

European regulators have expanded the scope of Celgene's Revlimid to include its use as monotherapy for the maintenance treatment of adults with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation (ASCT).

According to the firm, Revlimid (lenalidomide) is the first and only licensed treatment in this setting and thus represents a major advance for those patients who tend to be younger than the average patient with the incurable blood cancer.

For patients who are newly diagnosed with the condition and eligible for ASCT, key treatment aims are to delay disease progression and achieve long-term control over multiple myeloma. As such, these patients typically receive induction therapy and high-dose chemotherapy with melphalan followed by ASCT.

"This treatment approach has been an established standard of care for over 20 years, but over half of patients who relapse do so within two to three years of ASCT. Considering that over half of those patients who relapse do so within 2 to 3 years of ASCT, the approval of a maintenance therapy for use after ASCT that may delay disease progression represents a major advance for these patients," Celgene said.

The decision to approve the drug was based on data from two cooperative group-led studies, CALGB 1001049 and IFM 2005-02, which both had the primary efficacy endpoint of progression-free survival (PFS) from transplant to the date of disease progression or death.

In the CALGB 100104 trial, after 81.6 months of follow up, median PFS was 56.9 months in the Revlimid arm and 29.4 months in the placebo arm. In the IFM 2005-02 study, after 96.7 months of follow up, median PFS was 44.4 months in the Revlimid arm versus 23.8 months in the placebo arm.

"We now have an opportunity to enhance immune function and delay disease progression by controlling residual malignant cells and slowing tumour growth," said Professor Michel Attal, executive director of the Institut Universitaire du Cancer Toulouse Oncopole and Institut Claudius Regaud, France.

"Revlimid has been shown to increase progression-free survival after ASCT in clinical trials. Having a licensed therapy for use in this very important setting means we now have the opportunity to delay disease progression by sustaining the response".

Around 39,000 people are diagnosed with multiple myeloma and 24,000 die from it in Europe every year.

Revlimid is also approved as combination therapy for the treatment of patients not eligible for transplant who are newly diagnosed or those have received at least one prior therapy.