Health Canada has issued a NOC/c for Tecvayli in adult patients with r/r MM who received 3 prior lines of therapy, incl. a proteasome inhibitor, an immunomodulatory agent & an anti-CD38 mAb
The authorization was based on the P-I/II study (MajesTEC-1) which showed that patients treated with Tecvayli, a SC administered therapy showed deep and durable responses in a patient population with m-DoR of 14.9mos. among triple-class exposed patients
ORR (62.4%) with a median follow-up of 14.1mos., VGPR or better (57.6%) and CR (36.8%), the median time to the first confirmed response was 1.2mos., serious adverse reactions (65%), neurologic toxicities in 15% while immune effector cell-associated neurotoxicity syndrome in 3% of patients
Ref: Newswire | Image: Janssen
Related news:- Janssen’s Tecvayli (teclistamab-cqyv) Receives the US FDA’s Approval for the Treatment of Relapsed or Refractory Multiple Myeloma
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