Janssen’s Darzalex (daratumumab) Combination Regimen Receives Health Canada Approval for Transplant Ineligible Patients with Multiple Myeloma

 Janssen’s Darzalex (daratumumab) Combination Regimen Receives Health Canada Approval for Transplant Ineligible Patients with Multiple Myeloma

Janssen’s Darzalex (daratumumab) Combination Regimen Receives Health Canada Approval for Transplant Ineligible Patients with Multiple Myeloma

Shots:

  • The approval is based on P-III MAIA study assessing Darzalex + lenalidomide + dexamethasone (Rd) vs Rd as monothx. in 737 patients with newly diagnosed multiple myeloma who are ineligible for high-dose chemotherapy and ASCT aged 45-90 yrs.
  • The P-III MAIA study results: 44% reduction in risk of disease progression; CR (48% vs 25%); PR (79% vs 53%); ORR (93% vs 81%); patients achieving CR & better MRD negativity status (10-5) (24% vs 7%); @median-follow up of 28mos. mPFS (not reached vs 31.9mos.)
  •  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

Click here to­ read full press release/ article | Ref: Newswire Canada | Image: Ois.net

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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