Celgene’s Revlimid has received good news from both sides of the Atlantic, being granted expanded indication by the FDA and approval from the European Commission. 

The FDA has now approved Revlimid (lenalidomide) as a maintenance therapy for people with multiple myeloma who have already received an autologous stem cell transplant (ASCT).

The approval was based on the results of two large-scale studies comparing Revlimid maintenance therapy given until disease progression or unacceptable toxicity after ASCT versus no maintenance.

In the first study, Revlimid maintenance demonstrated a median progression-free survival of 5.7 years versus 1.9 years as well as a median overall survival of 9.3 years versus 7 years.

In the second study, Revlimid maintenance resulted in a median progression-free survival of 3.9 years versus 2 years and median overall survival of 8.8 years versus 7.3 years.

“In newly-diagnosed multiple myeloma, [ASCT] remains a viable option for many patients and often provides a strong response against the disease,” said Michael Pehl, president of Global Hematology and Oncology for Celgene. “By expanding the approval for Revlimid to include post-transplant maintenance, patients have the potential to maintain those responses and, importantly, delay progression of the disease.”

The FDA had previously approved Revlimid in 2006 for use with dexamethasone in patients with multiple myeloma who had received at least one prior therapy. Its indication was then expanded in 2015 to include newly diagnosed multiple myeloma patients ineligible for ASCT.

Meanwhile, the European Commission agreed with the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) for Revlimid announced only a few weeks ago, making the drug the first and only medicine licensed in Europe for use as post-autologous stem cell transplantation maintenance therapy in multiple myeloma.

The drug is now approved in Europe as a monotherapy for maintenance of patients with newly diagnosed multiple myeloma after ASCT.

The final approval was based on the same two studies used to inform the FDA’s approved indication decision.

The most common side effects associated with Revlimid were neutropenia (an abnormally low number of a particular type of white blood cell), thrombocytopenia (low platelet count), infections, and an increased incidence of second primary tumours.