Janssen’s Darzalex receives new multiple myeloma approval in Europe

Janssen has announced that its cancer drug Darzalex has been approved in a new indication by the European Commission.

The regulator has granted approval for the use of the drug in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, in the treatment of adult patients with multiple myeloma who have received at least one prior therapy.

This approval was based on positive data from the phase III POLLUX and CASTOR studies, which showed that the drug is able to significantly reduce the risk of disease progression or death when combined with standard of care regimens.

Previously, Darzalex was conditionally approved for use in this indication, but now that Janssen has provided additional study data, the European Commission has agreed to upgrade the approval from conditional to full.

Dr Catherine Taylor, haematology therapeutic area lead at Janssen in Europe, the Middle East and Africa, said: "This approval is an important step for people living with multiple myeloma across our region and offers some patients a new treatment option."

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