CHMP Issues Positive Opinion Recommending Subcutaneous Formulation of Daratumumab for the Treatment of Patients with Multiple Myeloma
Genmab A/S - American Depositary Shares (GMAB)
Company Research
Source: GlobeNewswire
Company Announcement Committee for Medicinal Products for Human Use issued Positive Opinion for subcutaneous formulation of daratumumab for the treatment of patients with multiple myelomaOpinion based on data from Phase III COLUMBA and Phase II PLEIADES studies Copenhagen, Denmark; April 30, 2020 – Genmab A/S (Nasdaq: GMAB) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a Positive Opinion recommending the use of the subcutaneous formulation of daratumumab for the treatment of adult patients with multiple myeloma in frontline and relapsed / refractory settings. The CHMP’s Positive Opinion for the subcutaneous formulation of daratumumab applies to all currently approved daratumumab indications in frontline and relapsed / refractory multiple myeloma settings. In August 2012, Genmab granted Janssen Biotech, Inc. (Janssen) an exclusive worldwide license to develop, manufacture and commercialize daratumumab.
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