Posted by Michael Wonder on 21 Nov 2017
Janssen seeks expanded use of Darzalex (daratumumab) from EMA in newly diagnosed multiple myeloma
21 November 2017 - Janssen-Cilag International today announced the submission of a Type II variation application to the EMA, for the immunotherapy Darzalex (daratumumab).
The application seeks to broaden the existing marketing authorisation to include daratumumab in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
The regulatory submission is now pending validation by the EMA and is supported by data from the Phase 3 ALCYONE (MMY3007) study.
