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Celgene's Revlimid scores first-of-its-kind myeloma indication in EU

Published on 27/01/17 at 03:32pm

Celgene’s Revlimid (lenalidomide) has become the first licensed monotherapy treatment for newly diagnosed multiple myeloma in patients who have undergone autologous stem cell transplantation (ASCT), thanks to a positive recommendation from the EMA’s Committee for Medicinal Products for Human Use (CHMP).

The decision was based on results of two Phase 2 studies of over a thousand participants which showed promising results compared to the current standard of care: induction therapy and high-dose chemotherapy with melphalan followed by ASCT. Despite a notably increased incidence of haematologic second primary malignancies compared to placebo in patients being treated with Revlimid, CHMP deemed the risk-benefit ratio as positive for the use of the drug.

“Studies show that maintenance treatment after ASCT with Revlimid may help control residual malignant cells and delay tumour growth by enhancing immune function,” explained 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.”

Tuomo Pätsi, president of Celgene in Europe, the Middle East and Africa (EMEA) added: “Despite substantial progress made so far in multiple myeloma treatment, it remains an incurable disease. We welcome this CHMP opinion as it confirms the important role that Revlimid plays in treating multiple myeloma, extending the use of Revlimid across the disease continuum. At Celgene, we aspire to turn some of the most challenging diseases, like multiple myeloma, into manageable conditions. Therefore, we will continue to invest more than one-third of our revenues back into research and development.”

Multiple myeloma is responsible for around 24,000 deaths out of the 39,000 diagnosed in Europe each year.

Matt Fellows

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