Singapore Health Sciences Authority Accepts NDA for Equecabtagene Autoleucel for Relapsed, Refractory Myeloma

The Singapore Health Sciences Authority (HSA) has accepted a New Drug Application (NDA) for equecabtagene autoleucel for patients with relapsed or refractory multiple myeloma who have received at least three prior therapies, according to a press release from IASO Biotherapeutics, the developer of the drug.¹

“Singapore is the first country where we have submitted an overseas NDA,” said Jinhua Zhang, founder, chairwoman, and CEO of IASO Biotherapeutics in the press release. “Upon NDA approval, we plan to implement an innovative model of ‘Manufactured in China, supplied overseas’, enabling the export of domestically produced autologous CAR [chimeric antigen receptor]-T therapies to other countries.”

Equecabtagene autoleucel demonstrated early, deep, and durable responses with manageable safety in the single-arm, open-label, phase 1b/2 FUMANBA-1 trial.² The overall response rate was 96%, and 75 of 103 patients (74.3%) achieved a complete response or better. The median progression-free survival (PFS) was not reached, and the 12-month PFS rate was 78.8%. Ninety-six patients (95.0%) achieved measurable residual disease negativity at a sensitivity threshold of 10⁻⁵.

In terms of safety, 96 patients (93.2%) experienced cytokine release syndrome, with 94 (97.9%) cases resolving with treatment. Two patients (1.9%) experienced immune effector cell–associated neurotoxicity syndrome that resolved with treatment.

Equecabtagene autoleucel previously received NDA approval from the US Food and Drug Administration in August 2024 and a Biologics License Application approval from China’s National Medical Products Administration in June 2023.³

References

1. IASO Bio announces acceptance of new drug application for equecabtagene autoleucel (FUCASO) by the Singapore Health Sciences Authority (HSA). PR Newswire. January 29, 2025. https://www.prnewswire.com/news-releases/iaso-bio-announces-acceptance-of-new-drug-application-for-equecabtagene-autoleucel-fucaso-by-the-singapore-health-sciences-authority-hsa-302363236.html
2. Li C, Zhou K, Hu Y, et al. Equecabtagene autoleucel in patients with relapsed or refractory multiple myeloma: the FUMANBA-1 nonrandomized clinical trial. JAMA Oncol. 2024;10(12):1681-1688. doi:10.1001/jamaoncol.2024.4879
3. IASO Bio receives U.S. FDA approval of Investigational New Drug Application for Equecabtagene autoleucel for two new autoimmune disease indications. PR Newswire. August 12, 2024. Accessed January 29, 2025. https://www.prnewswire.com/news-releases/iaso-bio-receives-us-fda-approval-of-investigational-new-drug-application-for-equecabtagene-autoleucel-for-two-new-autoimmune-disease-indications-302219682.html