CHMP give go ahead to expand REVLIMID as maintenance therapy for multiple myeloma

Celgene will use REVLIMID as a monotherapy to reduce risk of remission after autologous stem cell transplantation


The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the use of REVLIMID (Lenalidomide) as monotherapy for the maintenance treatment of adult patients with newly diagnosed multiple myeloma (MM) who have undergone autologous stem cell transplantation (ASCT).

Lenalidomide is used for treating anaemia in patients who have certain types of myelodysplastic syndrome (MDS). It is also used to treat mantle cell lymphoma (MCL) in certain patients. Typically, it is used along with dexamethasone to treat MM in certain patients.

MM is an incurable and life-threatening blood cancer that is characterised by tumour proliferation and suppression of the immune system. Around 39,000 people are diagnosed with MM in Europe a year. Around 24,000 of these patients die.

In Europe, patients who are under 65 years and in good clinical condition are typically considered eligible for ASCT. The median age at diagnosis in Europe is between 65 and 70 years.

For newly diagnosed, transplant-eligible MM patients, the aim is to delay disease progression. Patients typically receive induction therapy and high-dose chemotherapy with melphalan followed by ASCT. Over half of patients relapse within 2 to 3 years after the procedure.

To reduce this figure, trials have been conducted to assess whether maintenance therapy following ASCT could enable more durable remissions.

“Studies show that maintenance treatment after ASCT with REVLIMID may help control residual malignant cells and delay tumour growth by enhancing immune function,” said Professor Michel Attal, Executive Director of the Institut Universitaire du Cancer Toulouse Oncopole and Institut Claudius Regaud, France.

“Our primary goal is to delay disease progression for as long as possible and we have seen in several independent studies that REVLIMID maintenance after ASCT can halve the risk of disease progression by sustaining the response.”

Once approved by the European Commission, REVLIMID will be the first and only licensed maintenance treatment available to patients.

Celgene has said they will invest more than one-third of their revenue back into research and development.

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