Pfizer deposita in EMA la domanda di autorizzazione per elranatamab nel mieloma multiplo
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EMA has released its list of applications for new medicines under evaluation by the CHMP in February 2023, confirming the submission of Pfizer's elranatamab (PF-06863135) marketing authorization application (MAA) and start of evaluation on 26 January 2023, its B-cell maturation antigen (BCMA)-CD3-targeted bispecific antibody (BsAb) for the treatment of relapsed/refractory multiple myeloma (MM).
The list also confirms that elranatanab will be evaluated under standard assessment timelines by the EMA (approval expected in 1Q/2024).
Elranatamab was initially granted a PRIME designation by the EMA; however, contrary to expectation for a product granted PRIME designation, the MAA will not qualify for accelerated assessment.
source: applications for new human medicines under evaluation by the CHMP - February 2023