OS Therapies Seeks Expedited FDA Approval Following Successful Mid-Stage Osteosarcoma Trial
Successful Trial:
OS Therapies has announced that its Phase 2b clinical trial of OST-HER2 has achieved its primary endpoint, paving the way for potential FDA approval3.
Expedited Approval:
The company aims for speedy FDA approval following this mid-stage success in treating osteosarcoma5.
Future Plans:
OS Therapies plans to pursue therapeutic development of OST-HER2 in breast cancer after potential FDA approval for osteosarcoma1.
Context:
The FDA has shown a willingness to grant accelerated approvals for treatments of rare and serious diseases, as seen with Lartruvo for soft tissue sarcoma4.
Competitive Landscape:
Other treatments, such as LSTA1, have received orphan drug designation and rare pediatric disease designation from the FDA for osteosarcoma, highlighting the ongoing efforts to address this unmet medical need2.
Sources:
1. https://www.stocktitan.net/news/OSTX/os-therapies-forms-osteosarcoma-patient-advocacy-advisory-pweekmmidpkt.html
2. https://www.onclive.com/view/fda-grants-orphan-drug-designation-to-lsta1-in-osteosarcoma
3. https://www.streetinsider.com/Corporate+News/OS+Therapies+(OSTX)+Announces+Phase+2b+Clinical+Trial+of+OST-HER2+Achieves+Primary+Endpoint/24209206.html
4. https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-new-treatment-advanced-soft-tissue-sarcoma