Folotyn (pralatrexate), a drug which made waves after results of a phase II trial were revealed at last year's American Society of Hematology meeting, was granted accelerated approval for peripheral T-cell lymphoma on Friday. (You can read more about the PROPEL study from CURE's 2008 ASH coverage
The approval is a first for PTCL, a rare and aggressive type of lymphoma that does not have many treatment options. The FDA based its decision on an improved overall response rate with the drug. While progression-free survival or overall survival (common endpoints in clinical trials) have not yet been demonstrated in a study, the improvement in response rate was enough for the FDA to give a green light to Folotyn because of PTCL's aggressive nature and lack of successful treatments. Additional studies of the drug will be ongoing to further assess clinical benefit.
The drug's manufacturer, Allos, has established a patient assistance program to help with reimbursement issues once the drug is available, which is projected to be early October. Patients can learn more about ASAP (Allos Support for Assisting Patients) by calling 877-272-7102 or visiting www.getASAPinfo.com