Celgene Corp has been boosted by the news that US regulators have approved a supplemental New Drug Application for Revlimid (lenalidomide) for the treatment of patients with mantle cell lymphoma.
Specifically, the US Food and Drug Administration has given the green light to Revlimid (lenalidomide) for patients whose disease has relapsed or progressed after two prior therapies, one of which included Takeda and Johnson & Johnson's Velcade (bortezomib). The approval for MCL, a rare subtype of non-Hodgkin’s lymphoma (NHL) occurring in less than 10% of patients with the latter, also marks the first oral therapy for patients with MCL.
Revlimid was originally approved by the FDA in 2006 for patients with multiple myeloma who had undergone at least one prior treatment. It then expanded the label for a certain subset of patients with myelodysplastic syndromes (MDS).
The latest approval went down well with the Leukemia & Lymphoma Society across the pond. Clare Karten, the latter's senior director of mission education, said that "despite advances in treatment, most MCL patients relapse over time, so lenalidomide is a welcome effective treatment option for these patients".
Revlimid is comfortably Celgene's biggest earner and first-quarter sales topped $1 billion. The new indication is expected to add around $100-$200 million to that figure.