Darzalex March Continues with EU Approval
Executive Summary
The latest approval for Johnson & Johnson's monoclonal antibody therapy Darzalex in multiple myeloma keeps the product firmly on course as a much-needed new option in relapsed/refractory patients but competition in the market is hotting up all the time.
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Darzalex made a splash with impressive Phase III data in relapsed multiple myeloma at the EHA and ASCO meetings, but a range of other drugs are on the way, including a next-generation CD38 inhibitor from Sanofi, checkpoint inhibitors and Roche's BCL-2 Venclexta.
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Accelerated EU Committee Nod for J&J/Genmab's Darzalex
Janssen-Cilag (Johnson & Johnson) and Genmab's CD38 monoclonal antibody product Darzalex (daratumumab) has been granted the green light for approval in adults with relapsed and refractory multiple myeloma, under an accelerated procedure.