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Celgene pulls EU application for early use of cancer drug Revlimid

Unable to comply with EMA’s request for additional data

Celgene will no longer seek European approval for an early-use indication for its blood cancer drug Revlimid after deciding it would not be able to meet European regulators' demands for additional clinical data.

Revlimid (lenalidomide) is currently approved in Europe in combination with dexamethasone to treat adults with multiple myeloma whose disease has been treated at least once in the past.

Celgene wanted to extend this indication to include maintenance treatment of newly-diagnosed multiple myeloma patients who have not progressed following initial treatment with melphalan, prednisone and Revlimid or following autologous stem cell transplantation.

But the US-based company has now withdrawn this application in the face of a request from the EMA's Committee for Medicinal Products for Human Use (CHMP) for more data to determine if the drug's benefits outweigh its risks in this setting.

The decision means Celgene misses out on an additional market for what is already its best-selling drug and had been predicted to reach peak-year sales of $1bn. Consequently the company's share prices fell 11 per cent following the announcement.

In addition to dropping its application for the extra indication, Celgene also pulled a request for EMA approval for two new strengths of Revlimid and a variation to add new pack sizes of seven capsules for the existing 5mg, 10mg, and 15mg strengths.

The company said it will resubmit these application at a later date, however, and it will re-evaluate the drug's US submission. However, plans to file for approval in Switzerland, Australia and other markets will still go ahead.

The news comes the same week that rival multiple myeloma treatment Kyprolis from Onyx Pharmaceuticals received unanimous backing from a US Food and Drug Administration (FDA) to treat patients with relapsed and refractory multiple myeloma who have received at least two prior therapies, including both a proteasome inhibitor, and an immunomodulatory agent (IMiD). Onyx has yet to apply for the drug's marketing approval in Europe.

22nd June 2012

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