Shares of Can-Fite Biopharma (CANF) were up 95.24% today after announcing the FDA has given a fast track designation for its liver cancer drug. The company’s drug CF-102 has been given Fast track designation for second-line treatment of hepatocellular carcinoma — liver cancer. Can-Fite is currently testing out CF-102 in a phase 2 trial in patients with Child-Pugh Class B cirrhosis. This CF-102 drug will be tested against a placebo compound to determine which drug provides greater efficacy.
One thing to note is that the patients listed above had already failed treatment with the only other FDA approved drug for this indication, Nexavar. The dose being used in the phase 2 trial is 25 mg of CF-102. That is because in a prior phase 1/2 trial Can-Fite established the 25 mg dose as being the most efficacious in the patients that were tested.
Fast track status is given to biotechnology companies to get a drug out to market quicker than other drugs. This type of status is most typically given to drugs that meet the requirement of treating an unmet medical need where patients don’t have many options available to them. This status allows more communication between the FDA and Can-Fite and speeds up the approval process. In addition this status also allows companies to file the NDA on a rolling basis — meaning as the data comes in company can keep updating FDA of their new results.
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