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On June 4, 2020, the subcutaneous formulation of daratumumab (dara) was granted marketing authorization by the European Commission for the treatment of adult patients with multiple myeloma (MM).1
The new formulation is approved for all indications that were previously treated with intravenous dara, but with a fixed dose of 1,800 mg dara plus 30,000 units hyaluronidase administered subcutaneously into the abdomen over 3–5 minutes. The current indications of dara approved in Europe are:
Review on the MM Hub the results leading to the approval of the subcutaneous dara from the COLUMBA trial and the PLEIADES trial. This approval promises to improve patient experiences of dara treatment across Europe, by reducing administration time whilst maintaining clinical activity and safety.
The MM Hub has been focusing on the ongoing potential of monoclonal antibodies in MM as an editorial theme, find more information on these agents discussed here.
BusinessWire. European Commission grants marketing authorisation for DARZALEX®(daratumumab) subcutaneous formulation for all currently approved daratumumab intravenous formulation indications. https://www.businesswire.com/news/home/20200604005487/en/European-Commission-Grants-Marketing-Authorisation-DARZALEX%C2%AE%E2%96%BC-daratumumab. Published June 4, 2020. Accessed June 8, 2020.
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