Janssen’s Talvey (talquetamab) Receives the US FDA’s Accelerated Approval for Heavily Pretreated Multiple Myeloma
Shots:
- The US FDA has granted accelerated approval of Talvey (bispecific T-cell engaging Ab) for adult patients with r/r MM who have received four prior lines of therapy, incl. a proteasome inhibitor, an immunomodulatory agent & an anti-CD38 Ab
- The P-II study (MonumenTAL-1) results of talquetamab showed an ORR of ≥70% with durable responses. At the SC biweekly dose of 0.8mg/kg & weekly dose of 0.4mg/kg, ORR (73.6% & 73.0%); VGPR or better (58% & 57%) with a median follow-up of 6 & 14mos.; CR or better (33% & 35%); m-DoR (not reached in biweekly dose) & (9.5mos. in weekly dose), respectively
- 85% of responders-maintained response for 9mos. in patients with biweekly doses. Talvey is available through a restricted program Tecvayli & Talvey risk evaluation and mitigation strategy
Ref: PR Newswire | Image: Janssen
Related News:- Janssen’s Tecvayli (teclistamab) Receives Health Canada Authorization for Relapsed or Refractory Multiple Myeloma
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