BioCentury
ARTICLE | Clinical News

Subcutaneous daratumumab non-inferior to IV formulation in Phase III

February 25, 2019 8:05 PM UTC

Genmab A/S (CSE:GEN; Pink:GMXAY) said subcutaneous daratumumab met the co-primary endpoints of non-inferiority to IV daratumumab in the Phase III COLUMBA (MMY3012) trial to treat relapsed or refractory multiple myeloma. Partner Janssen Biotech Inc. told BioCentury it plans to submit regulatory applications next half in the U.S. and EU for the subcutaneous formulation.

The IV formulation of daratumumab is approved as Darzalex for use in several settings to treat MM, as monotherapy and in combinations. The Johnson & Johnson (NYSE:JNJ) unit reported 2018 sales for the human IgG1k mAb against CD38 of $2.03 billion (see "Genmab's Blockbuster Darzalex Surpasses $2B in Sales")...

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CD38