Janssen/Genmab Win 1st Anti-CD38 In Multiple Myeloma
This article was originally published in Scrip
Johnson & Johnson Inc.'s subsidiary Janssen Biotech Inc. and its partner Genmab AS were the latest beneficiaries of the FDA's swift acting Office of Hematology and Oncology Products, which approved the firms' multiple myeloma drug Darzalex (daratumumab) well ahead of its March 9, 2016 expected goal date and just two months after the FDA accepted the medicines biologics license application (BLA).
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Positive top-line results from the MAIA study of daratumumab as a front-line treatment for multiple myeloma highlights the future sales growth potential of Genmab/J&J's CD38-targeted antibody, which could become the market leader in the sector in the next five years.
Janssen Biotech has won FDA approval for Genmab-licensed Darzalex in newly diagnosed multiple myeloma. However, the drug was approved in a combination that is not commonly used in the US. A further label expansion will provide a bigger boost to the anti-CD38 antibody's commercial prospects.