CARVYKTI® (ciltacabtagene autoleucel) achieved statistically significant and clinically meaningful improvement in OS in landmark CARTITUDE-4 study
“CARVYKTI, a one-time infusion, is now the first cell therapy to significantly improve overall survival versus standard of care for patients with myeloma as early as second line,” said Jordan Schecter, M.D., Vice President, Disease Area Leader, Multiple Myeloma, Johnson & Johnson Innovative Medicine. “As we continue to strive to change outcomes and advance care for every person living with multiple myeloma, we’re excited to share these results, which add to the growing body of evidence across our portfolio of differentiated, complementary therapies that attack the disease in different ways throughout the course of a patient’s journey.”
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“Most of the PMB-102 trial participants relapsed after CD19 CAR T therapy and/or presented with CD19 negative tumors. PMB-CT01 could present a viable alternative option for patients facing this challenging scenario,” said Hazel Cheng PhD., COO of PMB. “We are deeply committed to the development of this first-in-class BAFFR CAR
“We are encouraged that the two-year follow-up data for Columvi reinforces its potential to extend the lives of many patients where prognosis has historically been poor,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “These findings demonstrate the potential lasting benefits of early and
Søren Bregenholt, CEO of Alligator Bioscience, commented: “The orphan designation to HLX22 in Europe represents another important regulatory milestone for this program. Following the earlier FDA designation, this reinforces the potential clinical and commercial value of the antibody. While Alligator is not directly involved in the development, we look forward
Abbisko Therapeutics announced that its self-developed, highly selective small molecule FGFR4 inhibitor, irpagratinib, has received approval of Breakthrough Therapy Designation from the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) for the treatment of Hepatocellular Carcinoma (HCC). Irpagratinib is the first therapeutic agent to leverage
