> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Meeting to Review Survival Data for Osteosarcoma Therapy
- URL: https://www.fdaweb.com/fda-meeting-to-review-survival-data-for-osteosarcoma-therapy/
- Published: 2026-08-14T12:00:00.000Z
- Updated: 2026-09-14T13:45:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161627

FDA has granted OS Therapies a Type C statistical methods meeting with CBER to discuss 2.5-year overall survival data for OST-HER2, the company’s investigational immunotherapy for preventing or delaying recurrence in patients with fully resected, pulmonary metastatic osteosarcoma. OS Therapies says an interim three-year overall survival analysis is expected in early September.

The company said the meeting will focus in part on the appropriate comparator for interpreting the efficacy of OST-HER2\. Specifically, FDA and the company are expected to discuss whether pooled, non-concurrent published historical control data or concurrent natural-history data generated through the company’s OST-400 study should be used.

OS Therapies said overall survival at 2.5 years remained unchanged from the two-year timepoint, which the company characterized as evidence of a sustained survival benefit.

“We are heartened that overall survival at the 2.5-year timepoint remained unchanged from the 2-year timepoint,” said **Craig Eagle**, OS Therapies’ chief medical advisor and a member of its board.

The company expects the upcoming FDA meeting, along with the three-year survival data, to inform pending requests for Regenerative Medicine Advanced Therapy designation and a potential rolling BLA review request.

OS Therapies says it is seeking accelerated approval of OST-HER2 by the end of 2026\. The therapy has already received FDA Orphan Drug, Fast Track and Rare Pediatric Disease designations.

OST-HER2 is described as a gene-edited, Listeria-based immunotherapy designed to stimulate an immune response against HER2-expressing cancer cells. OS Therapies reported positive results from its Phase 2b study in patients with fully resected pulmonary metastatic, including its 12-month event-free survival primary endpoint and an overall survival secondary endpoint.

Additionally, the company said FDA has accepted its letter of intent requesting a Commissioner’s National Priority Review Voucher, which would provide an expedited agency review.