FDA Grants Fast Track Designation to Can-Fite for Liver Cancer Drug
The FDA has doled out a fast track designation to Israeli biotech company Can-Fite for its liver cancer therapy for second-line treatment.
CF-102 was classified as an orphan drug by the agency. It binds to an adenosine chemical receptor that shows up most frequently in tumor cells.
Bayer’s Nexavar is currently the only approved treatment for the disease.
Can-Fite’s anti-tumor oral medication is in Phase 2 clinical trials in the U.S., Europe and Israel, and the trial’s 78-patient enrollment goal is expected to be met by summer 2016.
The placebo-controlled study is analyzing the therapy’s effect on people suffering from Child-Pugh Class B cirrhosis whose condition did not improve on Nexavar.
If approved, Can-Fite would be entering a market that Global Industry Analysts have valued at more than $2 billion this year. — Victoria Pelham