EMA Recommends Extension of Indications for Lenalidomide in Multiple Myeloma

New indication concerns maintenance treatment of patients with newly diagnosed disease who have undergone autologous stem cell transplantation

On 26 January 2017, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product lenalidomide (Revlimid). The marketing authorisation holder for this medicinal product is Celgene Europe Limited.

The CHMP adopted an extension to an existing indication as follows:

“Revlimid as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation.”

For information, the full indications for Revlimid will be as follows:

“Multiple myeloma
Revlimid as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation.
Revlimid as combination therapy is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.
Revlimid in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.

Myelodysplastic syndromes
Revlimid as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anaemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.

Mantle cell lymphoma
Revlimid as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma.”

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics, which will be published in the revised European public assessment report, and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinion.