Drug Profile

Pembrolizumab companion diagnostic - Foundation Medicine

Alternative Names: FoundationOne® CDx test - Foundation Medicine

Latest Information Update: 19 Sep 2024

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At a glance

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

No
New Molecular Entity No

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)

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