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On February 12, 2023, it was announced that equecabtagene autoleucel (previously known as CT103A), a BCMA-directed CAR T-cell therapy received both regenerative medicine advanced therapy and fast-track designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with relapsed/refractory (R/R) multiple myeloma (MM). This follows the orphan drug designation in February 2022 and investigational new drug approval by the U.S FDA in December 2022.1
The Multiple Myeloma Hub previously reported the phase I clinical data of equecabtagene autoleucel in patients with RRMM which demonstrated increased persistency and efficacious responses, including those treated with prior murine BCMA CAR T-cell treatment. The updated phase Ib/II study results of the ongoing FUMANBA-1 trial (NCT05066646) were presented by Li2 during the European Hematology Association (EHA) 2022 Congress. Key results at the data cut off for the 79 evaluable patients with RRMM who were previously treated with at least three lines of therapy were as follows:
Additional ongoing clinical trials with equecabtagene autoleucel are:
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To help navigate the exciting content being presented at the EHA2022 Congress, the Multiple Myeloma Hub Steering Committee members have provided their recommendations for the top abstracts to look...
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