Logo

Janssen Receives EMA’s CHMP Positive Opinion for Talvey (talquetamab) and Tecvayli (teclistamab) to Treat Relapsed and Refractory Multiple Myeloma

Share this
Janssen

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

PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com

Click here to­ read the full press release 

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.

Share this article on WhatsApp, LinkedIn and Twitter

Related News/Articles

Join the PharmaShots family of 12000+ subscribers

I accept the Terms and Conditions