Revlimid, Celgene Corporation (NASDAQ:CELG)’s flagship blood cancer drug, has done very well in the first half of 2013 and increased its market share. After registering sales of $3.8 billion last year, the drug contributed $1 billion – 16.5% more than the same quarter prior year – to Celgene Corporation (NASDAQ:CELG)’s first quarter fiscal 2013 revenue.
Early this year, Revlimid got approval for the Chinese market under condition of an import license, meaning that a formal launch was imminent. Later in June, the FDA approved it as supportive treatment for mantle-cell lymphoma.
Spanner in the works
However, Britain’s NICE put a spanner in the works and issued a draft guidance saying that Revlimid was not worthy of the price tag it carried for treatment of myelodysplastic syndromes on concerns of uncertainty over whether it can improve survival in patients with serious bone marrow disorders.
If the draft guidance is confirmed, U.K.’s National Health System will not recommend Revlimid for use in Britain.
Good news soon followed in the shape of positive results from the Phase III clinical study termed Front-Line Investigation of Revlimid/Dexamethasone vs. Standard Thalidomide or FIRST. The primary goal of the study was progression-free survival (length of time during and after medication during which cancer being treated does not get worse). The secondary goals included response rate and overall survival rate, and safety and quality of life. The company said that the Revlimid/ dexamethasone combo helped patients live longer without the disease progressing as compared to a combination of melphalan, prednisone and thalidomide.
Everything is going right for Revlimid and in turn for Celgene Corporation (NASDAQ:CELG). The company is slated to reveal further information from the FIRST study in a medical conference later but whatever that information may be, the bottom line is that the results are solid. Revlimid, which is already a leading second-line treatment, could well get approved as a first-line treatment. For this purpose, the company intends to apply for expanded approval in the U.S. as well as Europe and other markets.