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OS Therapies召开FDA C型会议，讨论OST-HER 2 2B期试验，以预防或延迟复发性、完全切除的肺转移性骨肉瘤，并打算在2026年1月底之前提交BLA
2025-12-15 19:13
- FDA confirmed that data from single-arm studies in rare diseases, such as in ultra-rare deadly pediatric cancer osteosarcoma, could support a Biologics Licensing Application (BLA) under Accelerated Approval Program pathway, as stated in FDA guidance documents
- FDA proposed confirmatory study design include additional osteosarcoma disease settings such as prevention of recurrence following primary tumor resection, where a randomized controlled study may be feasible and that the confirmatory study would have to be underway prior to granting a BLA
- FDA indicated that the use of canine data to support confirmation that pre-specified immune biomarker activation is correlated with treatment-emergent human clinical benefit will depend on biomarkers chosen for evaluation & clinical validation thereof
- FDA requested follow-up meeting once immune activation biomarker analysis is available to review data within context of pending Company-planned BLA filing
- Key Opinion Leader Dr. Peter Anderson, who participated in the meeting following FDA's request that a key opinion leader be present to help educate the agency on the standard of care in osteosarcoma, noted that immunotherapies such as OST-HER2 are the most promising treatment category being investigated
- Company anticipates immune activation biomarker analysis data will be released during week of the JP Morgan Healthcare Conference in January 2026
- Company reiterates end of January 2026 timeline for planned BLA submission, with FDA-proposed meetings to review biomarker data & additional clinical data, as well as final confirmatory study design, expected to occur after BLA filing
- FDA feedback received remains in alignment with the Company's international regulatory strategy - including the United Kingdom and European Union
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