Celgene UK’s Revlimid® (lenalidomide) approved by EC as monotherapy for maintenance treatment of newly diagnosed multiple myeloma patients

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Celgene UK has announced the approval by the European Commission (EC) of lenalidomide as monotherapy for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation (ASCT).

Lenalidomide is the first and only licensed maintenance treatment available to these patients.

The lenalidomide marketing authorisation has been updated to include this new indication, which expands on the existing multiple myeloma indications as combination therapy for the treatment of those not eligible for transplant who are newly diagnosed, or have received at least one prior therapy.

For patients who are newly diagnosed with multiple myeloma and eligible for ASCT, key treatment goals are to delay disease progression and ultimately achieve long-term control over multiple myeloma. 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 two decades.

Over half of those patients who relapse do so within two to three years of ASCT, therefore the approval of a maintenance therapy for use after ASCT that may delay disease progression represents a major advance for these patients.

Multiple myeloma is the biggest blood cancer killer in the UK, with less than half of people diagnosed in England and Wales surviving for five years or more. Patients with this incurable disease live with the constant uncertainty of relapse, and require an effective targeted treatment at every stage of the cancer.

Professor Graham Jackson, Consultant Haematologist at Newcastle Hospitals NHS Foundation Trust, said: “Multiple myeloma remains an incurable cancer and as clinicians we are always looking for different treatment approaches to help achieve the best quality remission for patients.” 

The EC decision for this use of lenalidomide follows the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) in January 2017.