Pyxis Oncology granted FDA Fast Track Designation for PYX-201 monotherapy in patients with recurrent or metastatic head and neck cancer

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Weekly Digest - February 2025

26 Feb 2025: Pyxis Oncology granted FDA fast track designation for PYX-201 monotherapy in patients with recurrent or metastatic head and neck cancer

The FDA has granted Fast Track Designation to Pyxis Oncology’s PYX-201 for treating adult patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) who have progressed after platinum-based chemotherapy and anti-PD-(L)1 therapy
PYX-201 is a first-in-concept antibody-drug conjugate (ADC) that targets Extradomain-B Fibronectin (EDB+FN), a structural component in the tumor extracellular matrix (ECM) highly expressed in various cancers
Pyxis Oncology is actively recruiting patients for its clinical trial and plans to collaborate with the FDA to accelerate PYX-201’s development
HNSCC is one of the most common and difficult-to-treat cancers, with nearly 50% of cases progressing to recurrent or metastatic disease and a median survival of less than a year

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