- Incyte's ( NASDAQ: INCY ) drug Pemazyre to treat a rare bile duct cancer called cholangiocarcinoma has been approved for use in Australia.
- The decision to approve for the indication had been made on the basis of overall response rate and duration of response and a continued approval depends on verification and description of benefit in confirmatory trials.
- The drug has also been approved in the United States, Europe, Great Britain, Canada and Japan.
- Pemazyre is not yet reimbursed in Australia, it is currently being made available to eligible patients via a co-pay access program.
- In the primary analysis of 108 patients enrolled in the trial, treatment with the drug resulted in an objective response rate of 37% with 3.7% of patients having a confirmed complete response and 33.3% having a confirmed partial response.
For further details see:
Incyte drug Pemazyre to treat rare cancer cholangiocarcinoma approved in Australia