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FDA Grants IPI-549 Fast Track Designation in Urothelial Carcinoma

Jason M. Broderick @jasoncology
Published: Wednesday, Mar 25, 2020

Infinity CEO Adelene Perkins

Adelene Perkins

The FDA has granted a Fast Track Designation to IPI-549 for use in combination with nivolumab (Opdivo) for the treatment of patients with advanced urothelial cancer, according to Infinity Pharmaceuticals, Inc., the manufacturer of the PI3K-gamma inhibitor.1

In their poster presented at the ASCO meeting, the researchers also noted that, “On-treatment blood samples showed evidence of immune activation and reduced immune suppression, including upregulation of IFNg-responsive factors, such as PD-L1 and CXCL9/10, and dose-dependent re-invigoration/proliferation of exhausted PD1+CD8+CD45RA- T cells, evidenced by Ki67 increases.”


  1. Infinity Receives Fast Track Designation for IPI-549 in Combination with the Checkpoint Inhibitor Opdivo for the Treatment of Advanced Urothelial Cancer. Published online March 25, 2019. Accessed March 25, 2019.
  2. Sullivan RJ, Hong DS, Tolcher AW, et al. J Clin Oncol 36, 2018 (suppl; abstr 3013) doi: 10.1200/JCO.2018.36.15_suppl.3013.

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