Janssen’s Talvey (talquetamab) Receives EC’s Conditional Marketing Authorization for the Treatment of Relapsed and Refractory Multiple Myeloma
Shots:
- The EC has granted conditional marketing authorization to Talvey as a monotx. for adult patients with RRMM who received 3 prior therapies
- The authorization was based on the P-I/II study (MonumenTAL-1) evaluating talquetamab, which showed ORR across 0.8mg/kg, q2w, and 0.4mg/kg, qw doses. 71.7% and 74.1% treated at 0.8mg/kg, q2w, and 0.4mg/kg, qw dose achieved a response with a median follow-up of 12.7 and 18.8mos, VGPR or better (60.8% and 59.5%) and CR (38.7% and 33.6%), respectively
- Responses were durable with m-DoR (not reached and 9.5mos.) in both doses; 76.3% and 51.5% maintained a response for 9mos., adverse reactions leading to treatment discontinuation due to ICANS (1.1%) & weight loss (0.9%). The results were presented at ASCO & EHA 2023
Ref: Globenewswire | Image: Janssen
Related News:- Janssen’s Talvey (talquetamab) Receives the US FDA’s Accelerated Approval for Heavily Pretreated Multiple Myeloma
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