Share
The US FDA granted orphan drug designation for the CART cell therapy to treat relapsed or refractory multiple myeloma. Credit: www.scientificanimations.com / commons.wikimedia.org.

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

The 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.

Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content.