Janssen Receives EMA’s CHMP Positive Opinion for Talvey (talquetamab) and Tecvayli (teclistamab) to Treat Relapsed and Refractory Multiple Myeloma
Shots:
- The EMA’s CHMP has adopted the positive opinion recommended conditional marketing authorization for Talvey as monotx. for adult patients with RRMM who have received 3 prior therapies and also recommended the approval of a Type II variation for teclistamab
- The recommendation was based on the results from the P-I/II study (MonumenTAL-1) presented at ASCO and EHA 2023 and P-I/II trial (MajesTEC-1) presented at ASCO 2023 evaluating talquetamab and teclistamab
- Talquetamab, a bispecific T-cell engaging Ab, and Teclistamab, an off-the-shelf bispecific Ab which are currently being studied in multiple monotx. & combination studies. Talquetamab received BTD from the US FDA in June 2022 & ODD from the EMA in Aug 2021 and from the US FDA in May 2021
Ref: Janssen | Image: Janssen
Related News:- Janssen’s Tecvayli (teclistamab) Receives Health Canada Authorization for Relapsed or Refractory Multiple Myeloma
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