Pfizer’s Elranatamab Receives the US FDA’s Breakthrough Therapy Designation for the Treatment of Relapsed or Refractory Multiple Myeloma
Shots:
- The US FDA has granted BTD for elranatamab (BCMA-CD3-targeted bispecific Ab) to treat patients with r/r MM
- The designation was based on the 6mos. follow-up data from cohort A of the P-II (MagnetisMM-3) evaluating elranatamab monothx. (76mg, qw, SC) in 123 patients that showed a manageable safety profile, ORR (61.0%) at a median follow-up of 6.8mos., 90.4% probability of maintaining a response ≥6mos., TEAE regardless of causality was CRS (57.9%), grade 1 (43.2%), or grade 2 (14.2%). The results will be presented at ASH 2022
- The therapy also received ODD; FTD & PRIME scheme from the US FDA and EMA for MM. Elranatamab has also received an Innovative Medicine Designation from the MHRA along with an Innovation Passport
Ref: Pfizer | Image: Pfizer
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