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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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Another Sea Change In Myeloma Promised By New Therapies, Combos

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.

CASTOR Propels J&J's Anti-CD38 Darzalex To Prime Position In Myeloma

Lead investigator says anti-38 antibody daratumumab compares well in earlier-stage relapsed disease to other myeloma drugs and advises using it early on the basis of "unprecedented" benefit.

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.

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