Genmab, the Danish biotechnology company, has announced that its collaborative partner, Janssen Biotech, Inc. has submitted a Market Authorisation Application to the European Medicines Agency (EMA) for daratumumab as a treatment for myeloma. Specifically, approval is being sought for daratumumab to be used as a treatment for myeloma patients in Europe who have had at least three previous lines of treatment including both a proteasome inhibitor and an immunomodulatory drug, or who are double refractory to both drug types. This follows the recent submission of the equivalent Biologics Licence Application to the US Food and Drugs Administration (FDA). Decisions from both the EMA and FDA are early next year.

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