Pfizer’s Reports the US FDA and EMA’s Acceptance of BLA and MAA for Elranatamab for Multiple Myeloma
- The US FDA has accepted the BLA for Priority Review of elranatamab, a BCMA CD3-targeted bispecific Ab for r/r MM. The US FDA’s decision is expected in 2023
- The EMA also accepted the MAA of elranatamab. The BLA & MAA was based on cohort A of the P-II study (MagnetisMM-3) evaluating elranatamab as monotx. in 187 patients which showed ORR (61%) of which 55% had a VGPR rate or better with a median follow-up of 10.4mos., patients maintaining the response @9mos. was 84% with a manageable safety profile
- A 2-step-up priming dose of 12 & 32mg mitigated the rate & severity of CRS and ICANS. All cases of CRS were grade 1 or 2 & the majority occurred after the first (43%) or second dose (24%), CRS after doses 3 & 4 were 6% & 1% with no fatal neurotoxicity events
Ref: Pfizer | Image: Pfizer
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