- Celgene's blood cancer drug Revlimid won approval in the European Union for treatment of advanced forms of mantle cell lymphoma, broadening use of the drug, the company said last week.
- Revlimid is already approved for treatment of multiple myeloma in both the U.S. and E.U., and has been the top earner for Celgene. Last year sales of Revlimid accounted for nearly 63% of total revenue.
- Mantle cell lymphoma (MCL) is a less common but particularly aggressive form of non-Hodgkin lymphoma (NHL), affecting between 3% and 6% of all NHL patients. With this new approval, Revlimd will compete against Imbruvica, which is co-marketed by AbbVie and Johnson & Johnson.
Revlimid is already used to treat relapsed and refractory MCL in other markets, most notably the U.S. Winning approval in Europe should help boost sales in that market. In its year-end earnings report for 2015, Celgene pointed toward market share gains in newly diagnosed multiple myeloma as a factor in increasing European revenue last year.
Celgene anticipates sales of Revlimid will continue to grow this year, forecasting between $6.6 billion and $6.7 billion in worldwide sales (2015 sales hit $5.9 billion).
But as Revlimid expands into MCL, Celgene will face competition from Imbruvica, which is quickly expanding its market share following its approval in the U.S. in 2013 and in the E.U. two years ago. Imbruvica is approved for several types of leukemia and lymphoma but not multiple myeloma, Revlimid's core area.
Revlimid's approval in MCL was supported by Phase 3 data which showed a median progression-free survival time of 8.7 months, versus 5.2 months in the control group.