NMPA approval for first BCMA CAR-T paves way for more multiple myeloma cell therapies

By Isabel Cameron

- Last updated on GMT

© Getty Images
© Getty Images

Related tags Clinical trial Oncology hematology

Nanjing Iaso Biotherapeutics and Innovent Biologics have received China National Medical Product Administration (NMPA) approval for Fucaso (equecabtagene autoleucel) as a treatment for patients with relapsed or refractory multiple myeloma who have received ≥3 lines of prior therapies.

Serving as the world’s first commercially available fully-human CAR-T therapy, Fucaso is set to experience a steady increase in annual sales over 2023-2029 by virtue of its first-to-market advantage and pave the way for more multiple myeloma cell therapies, according to GlobalData.

GlobalData forecasts Fucaso sales to reach $69 million in 2029. Fucaso’s approval was based on the FUMANBA-1 clinical study, a Phase I//II clinical trial which revealed favorable efficacy and safety results.

In particular, among the 103 subjects enrolled in the clinical trial, the overall response rate was 96% and the stringent complete response/complete response rate was 74.3%.

Verona Morina, oncology and hematology analyst at GlobalData, comments: “Fucaso is an autologous CAR-T cell injection that utilizes lentivirus as a gene vector to transfect T cells. The CAR-T therapy is directed against BCMA, an antigen that is highly expressed on multiple myeloma cancerous cells. Due to its single infusion nature, one of the desirable things about CAR-Ts is that it eliminates the requirement to repeatedly reinfuse.”

“This new paradigm is somewhat novel for refractory/relapsed multiple myeloma patients as conventionally, continuous combinational treatments until progression or intolerance is the norm for such patients. The approval of Fucaso is set to dramatically change the clinical and commercial landscape of CAR-T therapies in multiple myeloma as it drives physician familiarity and clinical uptake of such agents, as well as potentially evincing its successful safety and efficacy outcomes in practice.”

Morina concludes: “With only two CAR-T therapies approved for multiple myeloma, the current number of patients expected to receive CAR-T therapies globally in 2027 is 5,144 - with the approval of Fucaso and several other agents in the pipeline, this number is anticipated to significantly change and grow.

“However, whilst the uptake of CAR-T therapies is expected to increase, it is unclear whether the manufacturing and logistical capabilities of companies will be able to grapple with the enhanced demand; if not, this may overshadow its commercial success, thus, limiting patient uptake. As such, improvements in these areas will be vital for their continued success.”

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