Revlimid snags MCL nod in Europe to take on J&J's Imbruvica

Map of Europe

Celgene blood cancer giant Revlimid has picked up another European approval. But as the company gears up to launch the med in its new indication, it’s already got a familiar foe waiting to receive it.

Friday, the European Commission announced that it had green-lighted the blockbuster as a treatment for relapsed and refractory mantle cell lymphoma, a rare sub-type of aggressive non-Hodgkin’s lymphoma that affects between 3% and 6% of all NHL patients.

Regulators based the decision on a Phase II trial, in which Revlimid posted progression-free survival of 8.7 months versus 5.2 months in the control arm.

The label expansion should boost the med, which is already indicated to treat MCL in countries including the U.S., Switzerland, Israel, Turkey and Australia. That’s not to say Revlimid’s hurting for sales: Last year, it raked in $5.8 billion worldwide, an increase of $821.1 million over 2014’s global haul. European expansion played a role in that swell, with launch activities for the med in newly diagnosed multiple myeloma--an indication it won last February--continuing throughout the year on the continent.

But it’ll have to battle it out with Johnson & Johnson’s Imbruvica, which won its own European MCL nod back in October 2014. That quick-launching product--shared with AbbVie in the U.S.--competes alongside Revlimid in their home MCL market. Imbruvica may one day face off against Revlimid in another category, too: AbbVie CEO Richard Gonzalez has said the standout, which already treats chronic lymphocytic leukemia, could expand into other B-cell malignancies--including multiple myeloma, a Revlimid mainstay.

- read the release

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