# Center for Drug Evaluation and Research Biomarker Qualification Program

Type: Company

Source: Healthcare Intelligence Brief — https://gethealthbrief.com/entity/center-for-drug-evaluation-and-research-biomarker-qualification-progra
Canonical HTML page: https://gethealthbrief.com/entity/center-for-drug-evaluation-and-research-biomarker-qualification-progra

## Timeline

- **2026-09**: Interim 3-year overall survival data expected — Company expects to announce interim 3-year overall survival data from the Phase 2b OST-HER2 trial in early September 2026.
- **2026-09**: FDA Type C Statistical Methods Meeting — Meeting expected in mid-September 2026 with CBER to review statistical methods, comparator appropriateness, RMAT designation, and rolling review.
- **2026-09**: MHRA Scientific Advice Meeting — UK MHRA meeting expected in September 2026 to review statistical methods supporting the CMAA, including finalization with 2.5-year overall survival.
- **2026-08-13**: Company announces FDA Type C meeting and MHRA parallel review — OS Therapies announces FDA granted Type C Statistical Methods Meeting to review 2.5-year OS data for OST-HER2; MHRA Scientific Advice Meeting granted in parallel.

## Recent coverage (1 stories)

### FDA Type C Meeting to Review 2.5-Year OS Data in Osteosarcoma
2026-08-14 01:42:06 · Sentiment: Positive · Impact: 7/10 · Sources: 2

For healthcare regulators and health systems, OS Therapies' FDA Type C meeting on OST-HER2 will test whether historical control data can support approval in rare osteosarcoma. With MHRA running parallel advice and a biomarker qualification review pending, the case could reshape evidence standards in ultra-rare cancers.
Full story: https://gethealthbrief.com/story/fda-type-c-meeting-ost-her2-health

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