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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.”

References

  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. https://yhoo.it/2vOFts9. 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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