Celgene’s Revlimid has been approved in the USA to treat multiple myeloma patients who have failed to respond to a previous treatment, adding to its existing indication as a treatment for a group of blood disorders known as myelodysplastic syndromes.

The US Food and Drug Administration approved Revlimid (lenalidomide) to treat multiple myeloma in combination with dexamethasone. Last month, Celgene won US approval to market its Thalomid (thalidomide) as a first-line treatment for the disease.

Prior to last month’s approval Thalomid was officially licensed only to treat leprosy, but was thought to be extensively used off-label already in multiple myeloma patients, helping it rack up sales of $388 million last year.

Revlimid will compete in the USA with Velcade (bortezomib) from Millennium Pharmaceuticals, which was approved to treat multiple myeloma in the USA in 2003 and is expected to achieve sales of around $250 million this year. Analysts at Morgan Stanley have predicted that Revlimid could achieve sales of more than $1 billion by 2008.

Meantime, the new indication for Revlimid will help Celgene boost its position in the multiple myeloma market, and also improve the prognosis for patients, as Thalomid has been unable to demonstrate an increase in survival in trials. Earlier this month, Celgene presented data demonstrating that Revlimid improved the rate of survival in previously treated patients with the blood cancer: in one of the studies more half than of the patients were still alive and stable or in remission 18 months after the trial started, compared to less than a quarter on dexamethasone alone.

Celgene also sells Alkeran (melphalan), which is used to treat multiple myeloma and ovarian cancer, under an agreement with GlaxoSmithKline.

Multiple myeloma, an incurable cancer of the plasma cell, is the second most common haematologic cancer, representing 1% of all cancer diagnoses and 2% of all cancer deaths.

- Meanwhile, analysts at Piper Jaffray say that, based on pricing data from Revlimid’s named-patient programme in the UK, which makes the drug available to needy patients prior to approval, they have raised their European sales forecasts for Revlimid from $400 million to $1 billion. They note that the UK programme price is around $8,400 a month, a significant premium over Velcade, and higher than the $4,500 monthly cost for the drug reported elsewhere.