Janssen Reports Submission of sBLA to the US FDA for Darzalex (daratumumab) based Combination Regimen for Relapsed/Refractory Multiple Myeloma
Shots:
- The sBLA is based on P-III CANDOR study assessing Darzalex + carfilzomib + dexamethasone (DKd) vs Kd as monothx. in 466 patients with r/r MM prior treated with 1L+ therapies at 120 sites globally
- The results of P-III CANDOR study support the benefits of triple regimen for patients with MM with 1EPs as PFS and 2EPs as ORR- OS and minimal residual disease
- 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 MM. In Aug’2012- Genmab granted exclusive rights of Darzalex to Janssen
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Ref: J&J | Image: Janssen
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