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Celgene’s Revlimid cleared for aggressive lymphoma type in EU

Analysts anticipate sales of up to $10bn for the newly-expanded drug in coming years

Celgene RevlimidThe European Commission has approved Celgene's Revlimid for a new indication that for the first time expands the drug's use beyond multiple myeloma in the EU.

The new labeling means that Revlimid (lenalidomide) can now be used to treat adults with relapsed or refractory mantle cell lymphoma (r/r MCL) a rare form of non-Hodgkin's lymphoma that remains highly resistant to current drugs.

People with r/r MCL have the poorest prognosis among all lymphoma patients, with fewer than half of them surviving beyond five years from diagnosis. The disease accounts for between 3% and 6% of all NHL cases and kills around 38,000 people in Europe every year.

Revlimid has been approved for MCL in the US since 2013, and the lymphoma indication is also on the drug's label in Switzerland, Israel, Turkey, Australia and various countries in Latin America.

The approval is based on the results of a phase II trial which showed an improvement in progression-free survival (PFS) in r/r MCL of 8.7 months, compared to just over five months among patients treated with the investigator's choice of current MCL drugs.

Revlimid has been Celgene's cash cow for years – growing at a healthy lick to $5.8bn last year thanks to ever broader use in multiple myeloma – and other new indications such as diffuse large B-cell lymphoma and follicular lymphoma have the potential to drive sales of the drug to $10bn in the coming years, according to some analysts.

New indications will be particularly important if that projected trajectory is to be maintained, as the myeloma space is starting to see increased competition. New launches such as Johnson & Johnson/Genmab's Darzalex (daratumumab) and Novartis' Farydak (panobinostat) are currently targeting relapsed myeloma but are expected to shift to earlier-stage treatment.

Some new drugs like Takeda's oral proteasome inhibitor therapy Ninlaro (ixazomib) have been approved for use in combination with Celgene's drug, but analysts suggest Revlimid could see direct competition in future from combinations, such as Darzalex plus Roche's checkpoint inhibitor atezolizumab which recently entered early-stage trials.

Article by
Phil Taylor

15th July 2016

From: Regulatory

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