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Janssen’s Tecvayli (teclistamab) Receives Type II Variation Application Approval from EC for Relapsed and Refractory Multiple Myeloma

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Janssen’s Tecvayli (teclistamab) Receives Type II Variation Application Approval from EC for Relapsed and Refractory Multiple Myeloma

Shots:

  • The EC has approved a Type II variation application of Tecvayli providing the option for a reduced dosing frequency of 1.5mg/kg, q2w
  • The approval was based on the P-I/II study (MajesTEC-1) evaluating teclistamab, presented at ASCO 2023 & EHA 2023. The results showed that teclistamab maintained deep & durable responses with the reduced onset of grade ≥3 inf. in eligible patients switching from weekly to a reduced biweekly dosing schedule
  • At the time of the switch, 85.7% achieved a CR or better, VGPR (12.7%), PR (1.6%), the median time to switch from first QW to first Q2W dose was 11.3mos., new onset of grade ≥3 inf. after 12-18mos. of follow-up was lower in responders who switched to Q2W dosing on or before 12mos. vs those who remained on QW dosing at 12mos. (15.6% vs 33.3%)

Ref: Globenewswire | Image: Janssen

Related news:- Janssen’s Tecvayli (teclistamab) Receives Health Canada Authorization for Relapsed or Refractory 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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