FDA Fast Track Designation for the Investigation of CTX-009 in Combination with Paclitaxel for the Treatment of Previously-treated Patients with Metastatic or Locally Advanced Biliary Tract Tumors
“We are delighted that CTX-009 has received FDA Fast Track Designation highlighting the large unmet need in patients with advanced BTC where current therapies have low, single digit response rates, and limited effect on patient survival,” said Thomas Schuetz, MD, PhD, Co-founder, President of R&D, and Vice Chairman of the Compass board. “Our current study is evaluating the combination of CTX-009 with paclitaxel following the observation of nine partial responses in 24 patients treated in our Phase 2 study, leading to an overall response rate of 37.5% (n= 9/24), a median progression free survival of 9.4 months and a median overall survival of 12.5 months. Compass remains on track to complete enrollment by mid-year and reporting top-line data by year end.”
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