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Janssen’s Talvey (talquetamab) Receives EC’s Conditional Marketing Authorization for the Treatment of Relapsed and Refractory Multiple Myeloma

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Janssen’s Talvey (talquetamab) Receives EC’s Conditional Marketing Authorization for the Treatment of Relapsed and Refractory Multiple Myeloma

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  • 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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Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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