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Celgene gets first-line myeloma approval for Revlimid

Approved in the EU and US for newly-diagnosed patients

Celgene Revlimid lenalidomideCelgene's flagship myeloma therapy Revlimid has been approved in the EU and US for newly-diagnosed patients, expanding the target population for the drug.

The extension to include first-line use - in addition to Revlimid's current approval in combination with dexamethasone for patients who have received at least one prior therapy - is expected to add momentum to the product's already buoyant growth.  Last year Revlimid sales grew around 16% to approach $5bn.

The European Commission (EC) approved Revlimid (lenalidomide) for the initial adult myeloma patients, who are not eligible for stem cell transplant, based on the results of two phase III studies.

One trial showed that Revlimid was able to improve progression-free survival (PFS) compared to first-line treatment with the widely used melphalan-prednisone-thalidomide (MPT). The second found that maintenance treatment with Revlimid was superior to melphalan-prednisone after an initial induction therapy based on Celgene's drug plus melphalan-prednisone.

"We have seen significant progress in the treatment of the disease over the years, with an improvement of more than 50% in five-year survival rates, but there continues to be a need for innovative new approaches," commented Celgene Europe's president Tuomo Pätsi.

The ultimate aim is to turn myeloma - which affects around 40,000 people in Europe - into a "manageable, long-term, chronic condition," he added.

Celgene said recently that strong growth for Revlimid as well as its newer products, including Pomalyst/Imnovid (pomalidomide) for myeloma - which the company predicts will become a multibillion-dollar product - as well as oral psoriasis therapy Otezla (apremilast), and cancer therapy Abraxane (nab-paclitaxel) would help it achieve $20bn in annual sales by 2020.

In addition to myeloma, Revlimid is also being tested in lymphoma - with five phase III trials ongoing in indications such as follicular and diffuse large B-cell lymphomas - which could drive additional sales momentum beyond 2017.

Article by
Phil Taylor

20th February 2015

From: Sales

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