FDA Fast Track Designation for ETX-19477 for BRCA-Mutated, Platinum-Resistant Ovarian Cancer Patients Announced 

“Patients with platinum-resistant ovarian cancer have a poor prognosis, and treatment options remain extremely limited, highlighting a substantial unmet need for new therapies,” said Jeffrey Stafford, Ph.D., CEO of 858 Therapeutics. “We are pleased that the FDA has granted Fast Track designation to ETX-19477 and we are committed to working closely with the FDA to accelerate its development. This designation was based on preclinical data and emerging clinical data from our ongoing Phase 1/2 trial of ETX-19477, including anti-tumor activity at tolerable doses.”

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