Japan’s PMDA approves Initiation of Clinical Trial for CAR-T Therapy Equecabtagene Autoleucel in 2L/3L Multiple Myeloma

Ms. Jinhua Zhang, Founder, Chairperson, and CEO of IASO Bio, commented: “Following the CTN clearance for Eque-cel in late-line r/r MM in Japan in October 2025, this subsequent clearance for second- or third-line indications further demonstrates the high recognition by Japan’s PMDA of the product’s clinical value and the strength of China’s clinical data. This also lays a solid foundation for us to efficiently advance global development of our products through the MRCT (multi-regional clinical trial) pathway. We will accelerate the progress of relevant clinical trials and look forward to benefiting more patients in Japan and around the world with this advanced China-developed CAR-T therapy as soon as possible.”

Share:

More News

“This research collaboration with AbCellera directly aligns with Jazz’s rare disease strategy, expanding our focus on GI cancers and building on our existing expertise in oncology,” said Josh Allen, Ph.D., chief scientific officer, oncology, Jazz Pharmaceuticals. “We look forward to collaborating with AbCellera to progress potential best-in-class TCE multispecific antibodies

AIM Chief Executive Officer Thomas K. Equels stated: “AIM hopes to utilize the exploratory biomarker data generated through DURIPANC to design a Phase 3 study involving Ampligen in the treatment of pancreatic cancer. We are particularly interested in evaluating whether specific biomarkers may help to identify ‘super-responder’ patient subsets most

“We are committed to improving the treatment of glioblastoma and are grateful to our investigators and the patients and families who made the TRIDENT trial possible,” said Uri Weinberg, MD, PhD, Chief Medical and Innovation Officer, Novocure. “The study did not meet its primary endpoint, but the results from TRIDENT

“Fast Track Designation is a valuable step forward for givastomig and for patients with first-line HER2-negative metastatic gastric cancer,” said Phillip Dennis, MD, PhD, Chief Medical Officer of NovaBridge. “Phase 1b results demonstrate robust efficacy and favorable overall tolerability in combination with immunochemotherapy. Responses were deep and durable across a