Pyxis Oncology, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to PYX-201. This designation is for the treatment of adult patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) whose disease has progressed following treatment with platinum-based chemotherapy and an anti-PD-(L)1 antibody.
Fast Track designation is an FDA program designed to facilitate and expedite the development and review of new drugs for serious or life-threatening conditions. To qualify, a drug must demonstrate the potential to address an unmet medical need in the designated condition.
This designation acknowledges the significant medical need in R/M HNSCC, a condition where almost 50% of cases progress to recurrent or metastatic cancer post-initial treatment, leading to a median overall survival of less than a year. The company anticipates this will help accelerate the development of PYX-201.
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