The Chinese National Medical Products Administration (NMPA) has granted approval for Innovent Biologics and IASO Biotechnology’s (IASO Bio) Fucaso (equecabtagene autoleucel) for treating relapsed or refractory multiple myeloma (RRMM) in adults.
The regulator accepted the new drug application (NDA) for the therapy in June 2023.
Fucaso is a completely human chimeric antigen receptor (CAR) T cell therapy directed at the B-cell maturation antigen. It utilises lentivirus as a gene vector for transfecting autologous T cells.
This treatment is indicated for usage in RRMM patients who have received a minimum of three lines of treatment, including an immunomodulatory agent and a proteasome inhibitor.
The approval for the application for Fucaso was based on the findings from the Phase I/II FUMANBA-1 clinical trial.
Carried out in China, the study evaluated the efficacy of cell therapy in RRMM patients with recently published data showing beneficial safety and efficacy profiles.
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By GlobalDataThe companies jointly oversee Fucaso’s development and marketing.
Innovent Biologics senior vice-president Dr Hui Zhou stated: “There’s an urgent unmet need for a treatment with well-tolerated and long persistence for RRMM patients in China.
“Fucaso, as an innovative fully human BCMA-directed T cell therapy, has demonstrated robust and long-lasting efficacy and outstanding safety in long-term follow-up data from the registrational clinical study, which underscores its potential to be a pioneering treatment option for patients with RRMM.”
The US Food and Drug Administration had earlier granted orphan drug designation for the CART cell therapy to treat RRMM.
Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.
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