FDA Filing Acceptance and Priority Review for TIBSOVO in the Treatment of IDH1-mutated R/R MDS announced
“Servier continues to drive our leadership in the scientific innovation behind targeted mutant IDH inhibition, transforming the treatment landscape for thousands of patients living with difficult and hard-to-treat cancers,” said Susan Pandya, M.D., Vice President Clinical Development and Head of Cancer Metabolism Global Development Oncology & Immuno-Oncology, Servier. “This filing acceptance and Priority Review for TIBSOVO in patients with relapsed or refractory myelodysplastic syndromes underscores our continued work to advance therapeutic progress across IDH mutated cancers, and if approved in this setting, will bring the first and only targeted therapy to patients living with a significant unmet need.”
Share:
More News
“Initiation of the TEADCO Phase 1b/2 basket trial is another important milestone for the ODM-212 clinical development program and reflects our commitment to patients with difficult-to-treat cancers,” said Professor Outi Vaarala, Executive Vice President, Research & Development at Orion. “Together with the ongoing TEADES study, TEADCO highlights the versatility of
“In this study, tovecimig showed an impressive overall response rate which translated into a clinically meaningful and highly statistically significant improvement in PFS for patients with previously treated BTC. The remarkable 56% reduction in the risk of disease progression is unprecedented in this patient population without an actionable mutation in
“We are encouraged to see taletrectinib (IBTROZI) added to the NCCN Guidelines® for CNS Cancers given its demonstrated high rates of intracranial response that are durable in ROS1+ NSCLC patients with brain metastases,” said David Hung, M.D., Founder, President and Chief Executive Officer of Nuvation Bio. “Given the prevalence of
Daniel Getts, Ph.D., CEO of CREATE, added “MT-304 is proof of what our platform can do, and what our team can execute. Our mRNA-LNP leadership enables us to move from concept to clinic with remarkable speed. Just last weekend at AACR, we presented compelling preclinical data across our in vivo