Janssen’s Tecvayli (teclistamab) Receives EC’s Conditional Marketing Authorization for Multiple Myeloma
Shots:
- The EC has granted CMA of Tecvayli as monothx. for r/r MM who received 3 prior therapies incl. an immunomodulatory agent, a proteasome inhibitor & an anti-CD38 Ab
- The CMA was based on the P-I/II (MajesTEC-1) study evaluating teclistamab in 165 adult patients which showed that 104 patients achieved an ORR (63%) after a median of 5 prior lines of therapy; VGPR (58.8%); CR (39.4%); median time to 1st confirmed response was 1.2mos. and m-DoR (18.4mos.) & also showed deep & durable responses, m-PFS (11.3mos.) & m-OS (18.3mos.)
- The therapy is being studied in multiple monothx. & combination studies. Under the license agreement with Janssen, OmniAb will receive $10M in milestones at 1st commercial sale of teclistamab in the UK, Italy, Germany, France, or Spain
Ref: Johnson & Johnson | Image: Johnson & Johnson
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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.
