Pembrolizumab companion diagnostic - Foundation Medicine
Alternative Names: FoundationOne® CDx test - Foundation MedicineLatest Information Update: 19 Sep 2024
At a glance
- Originator Foundation Medicine
- Class Diagnostic agents
- Mechanism of Action Undefined mechanism
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Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity No
Highest Development Phases
- Marketed Solid tumours
Most Recent Events
- 19 Sep 2024 Launched for Solid tumours (Diagnosis) in USA (unspecified route) prior to September 2024 (Foundation Medicine website, September 2024)
- 21 Feb 2022 US FDA grants approval for Solid tumours (Microsatellite Instability High status) in USA
- 17 Jun 2020 Registered for Solid tumours (Diagnosis) in USA (unspecified route)