Pfizer deposita in EMA la domanda di autorizzazione per elranatamab nel mieloma multiplo

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