Janssen receives CHMP recommendation for new Darzalex indication

Janssen has announced that its cancer drug Darzalex has been recommended for European regulatory approval in a new indication.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended broadening the existing marketing authorisation for Darzalex to apply to previously-treated multiple myeloma patients.

If approval is granted by the European Commission, the drug could be used in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.

This recommendation is based on positive safety and efficacy data from the phase III studies POLLUX and CASTOR.

Dr Catherine Taylor, haematology therapeutic area lead for Janssen in Europe, the Middle East and Africa, said: "I am heartened by this important and rapid recommendation which recognises the progress in multiple myeloma treatment."

Darzalex first received conditional approval from the European Commission as a monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma in May 2016.

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