Janssen Reports Submission of sBLA to the US FDA for Darzalex (daratumumab) based Combination Regimen for Relapsed/Refractory Multiple Myeloma

 Janssen Reports Submission of sBLA to the US FDA for Darzalex (daratumumab) based Combination Regimen for Relapsed/Refractory Multiple Myeloma

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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Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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