Janssen Reports MAA Submission to EMA for Approval of Talquetamab to Treat Multiple Myeloma
Shots:
- The submission was based on the P-I/II study (MonumenTAL-1) study evaluating talquetamab (off-the-shelf, bispecific T-cell engager Ab). The recent application was based on BLA submission in the US
- Patients treated with talquetamab (SC, 0.4mg/kg, qw) achieved 74.1% ORR & 73.1% at 0.8mg/kg, q2w; VGPR or better (59.4% & 57.2%); CR (33.6% & 32.4%); sCR (23.8% & 20%); m-PFS (7.5mos. & not mature) at a median follow-up of 14.9 & 8.6mos., respectively. The study results were presented at ASH 2022
- At both doses, AEs leading to the treatment discontinuation (4.9% & 6.2%); 8.4% & 13.8% had dose delays; 14.7% & 6.2% had dose reductions. Talquetamab received PRIME designation from the EMA in Jan 2021; BTD from the US FDA in June 2022; ODD in the EU & US in Aug & May 2021, respectively
Ref: Globe Newswire | Image: Janssen
Related News:- Janssen Reports the BLA Submission of Talquetamab to the US FDA for the Treatment of Relapsed or Refractory Multiple Myeloma
Click here to read the full press release
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.
