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Janssen Reports Submission of BLA to the US FDA for Darzalex (daratumumab) Subcutaneous Formulation for Multiple Myeloma

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Janssen Reports Submission of BLA to the US FDA for Darzalex (daratumumab) Subcutaneous Formulation for Multiple Myeloma

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  • The BLA submission is based on P-III COLUMBA & P-II PLEIADES studies. P-III COLUMBA study involves assessing Darzalex SC vs Darzalex IV in 522 patients with MM prior treated with 3L therapies. The P-II PLEIADES study involves assessing of Darzalex SC + D-VRd/D-VMP in 240 patients with r/r multiple myeloma
  • The BLA submission follows approval of Darzalex in combination with lenalidomide and dexamethasone based on P-III MAIA study & PR designation following sBLA supported by P-III CASSIOPEIA study
  • Darzalex is a CD38-directed antibody and is an approved therapy as monothx. or in combination with other drugs in multiple countries including the US for the treatment of multiple myeloma. In Aug’2012- Genmab granted exclusive rights of Darzalex to Janssen

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 Ref: Janssen | Image: Janssen


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