NMPA Approves FUCASO, the First Fully-human BCMA CAR-T Therapy, for the Treatment of Relapsed or Refractory Multiple Myeloma in China

Dr. Hui Zhou, Senior Vice President of Innovent Biologics, stated, “Multiple myeloma is a common hematology malignant disease with high incidence rate, and relapse and refractory are almost inevitable after current treatments. There’s an urgent unmet need of 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. We are very pleased with the approval of FUCASO® and hope it could benefit RRMM patients as the first approved BCMA CAR-T therapy in China.”

Share:

More News

“KEYTRUDA has helped transform the treatment of certain cancers, and we continue to pursue innovations that build on this breakthrough medicine to give patients and those who treat them better experiences,” said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. “If approved,

“We are disappointed for ovarian cancer patients desperately lacking new treatment options. There has been a great deal of work across the industry in this immunologically cold tumor, yet there are still few treatment options that improve survival in this very difficult-to-treat tumor type. We are still on track to

“The improvement in survival seen in ROSELLA, without an increased safety burden, brings us closer to delivering a new standard-of-care treatment for patients with platinum-resistant ovarian cancer,” said Bill Guyer, PharmD, Corcept’s Chief Development Officer. “We deeply appreciate the patients and investigators who participated in the trial, and we look

“We are grateful for the ongoing guidance and support from the FDA and are very pleased that the agency is fully aligned on our plans related to the Phase 3 trial,” said Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON. “The Phase 2 OVATION 2 study data are