Janssen's Darzalex (daratumumab- SC) Receives Health Canada Approval for the Treatment of Patients with Multiple Myeloma
Shots:
- The Health Canada has approved Darzalex SC (daratumumab) in four regimens across five indications in patients with MM- notably newly diagnosed- transplant-ineligible patients as well as relapsed/refractory patients
- The approval is based on P-III COLUMBA and P-II PLEIADES studies. The P-III study demonstrated a consistent ORR (41% vs 37%)- with PK & safety profile compared with Darzalex IV in patients with RRMS- 2/3rd reduction in systemic ARRs (13% vs 34%)
- In P-II PLEIADES study evaluates Darzalex SC + D-VMP in newly diagnosed transplant-ineligible patients & Darzalex SC + (D-Rd) in R/R patients prior treated with 1L therapy. In general- Darzalex SC reduces administration time from hours to minutes and demonstrates consistent efficacy with a reduction in administration-related reactions
Ref: PRNewswire | Image: Janssen
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