FDA grants Celgene's Revlimid new use as it moves toward $10B in sales

Celgene's ($CELG) powerhouse cancer drug Revlimid generated nearly $5 billion for the company last year and has now gotten yet another FDA nod which analysts believe will help it double that amount within 5 years.

The company said Wednesday that the FDA has approved Revlimid in combination with dexamethasone for patients newly diagnosed with multiple myeloma. It previously had been approved only for patients after they had already received at least one therapy.

The new designation may not mean a big revenue bump in the U.S., Reuters points out, because many doctors have already been prescribing Revlimid off label as a first-line treatment, although the company was prevented from marketing it that way.

But it could mean a bigger lift in Europe where there are about 93,600 people with the condition, compared to 88,499 in the U.S. Revlimid has been recommended in Europe as a treatment for untreated multiple myeloma patients who are not eligible for stem cell transplantation. There doctors there are not allowed to prescribe meds off label, so the financial punch for the drug could be substantial. The company also has an application pending in Japan for newly diagnosed patients.

Revlimid sales totaled $4.98 billion last year, up 16%. Of that, $2.92 billion came from the U.S. and $2.06 billion from the rest of the world, the company reported last month. It said it expects sales of the drug to reach $7 billion in 2017. Canaccord Genuity analyst John Newman recently wrote to investors that he thinks the drug will hit sales of $10 billion by 2020.

That is key for Celgene, which continues to get about two-thirds of its revenues from Revlimid, one of the most expensive drugs in the world. First approved in 2005 as a treatment for anemia associated with myelodysplastic syndromes, the drug's use expanded in 2006 to multiple myeloma, which now accounts for most of its sales, as well as for the rare blood disease mantle-cell lymphoma.

Celgene is pushing hard with other treatments, like its new myeloma treatment Pomalyst. It had sales of $680 million for 2014, its first full year on the market. The drugmaker hit a snag with that treatment in England last week, however. The price watchdog NICE rejected Imnovid, Pomalyst's name there, in final guidance. It said that its benefit did not justify its price. Celgene said it was in discussions with the agency to find a solution.

- here's the announcement
- get more from Reuters

Special Report: The top 10 most expensive drugs of 2013 - Revlimid - Celgene

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