Janssen’s Darzalex (daratumumab, SC) Receives Health Canada Approval for the Treatment of Patients with Multiple Myeloma

August 4, 2020 Auto Bot approval, Biotech, daratumumab, DARZALEX, Health Canada, Janssen, Latest, multiple myeloma, patients, receives, regulatory, Treatment 0

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

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