Submission of rolling BLA request for OST-HER2 to FDA to begin in Sep 2025
“It is clear from the End of Phase 2 Meeting that FDA is committed to finding paths forward to bring new therapies forward for osteosarcoma given the continued high mortality rates in this rare pediatric cancer,” said Paul Romness, MHP, Chair & CEO of OS Therapies. “We have already begun the work of preparing responses to FDA’s comments stemming from the meeting and look forward to beginning the rolling BLA submission later this quarter. We will continue the highly productive ongoing dialogue we have with FDA as it relates to OST-HER2’s potential to improve both Event Free Survival and Overall Survival in the fully resected, pulmonary metastatic osteosarcoma setting. We expect that the October 10th, 2025 workshop FDA and OSI are holding will provide the opportunity for stakeholders to coalesce around the key outcome measures that are clinically meaningful for the brave patients, their families and clinicians who help manage this difficult to treat patient population.”
Share:
More News
“These data underscore gotistobart’s potential to redefine treatment for patients with hard-to-treat squamous NSCLC whose disease has progressed after initial therapy and who face limited options,” said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. “In second- and later lines of treatment, the clinical relevance of novel
“The collaboration with Ratio represents an exciting opportunity to explore the potential of novel radiopharmaceutical approaches designed to address the complexity and heterogeneity of cancer,” said Ben Hickey, President of RayzeBio. “The combination of our respective technologies and complementary development expertise creates a strong foundation for generating a novel differentiated
“We believe these results mark a potentially important step forward in the treatment of EGFR exon 20 insertion mutation-positive non-small cell lung cancer,” said Fabio Benedetti, MD, Global Chief Medical Officer, Taiho Pharmaceutical. “To address the unmet medical needs of patients and their families, we will continue working closely with
“Recent clinical data validated KAT6 as a targetable mechanism in the treatment of HR+/HER2- breast cancer, including those with actionable mutations,” stated Charles Morris, MBChB, MRCP, Chief Medical Officer of Prelude. “Dual KAT6A/B inhibitors, however, demonstrated overlapping toxicities with current backbone therapies that may limit the utility in earlier lines