The FDA has approved Folotyn (pralatrexate injection, from Allos Therapeutics), a folate analog, as a single agent for the treatment of relapsed or refractory peripheral T-cell lymphoma (PTCL). This approval was based on overall response rates (complete response, complete response unconfirmed, and partial response as assessed by International Workshop Criteria) from the PROPEL trial, an open-label, single-arm, multicenter, international clinical trial that enrolled 115 patients with relapsed or refractory PTCL. The initial response assessment was scheduled at the end of cycle 1 of treatment. The data showed that 27% (29 of 109 evaluable patients) responded to Fotolyn with a reduction in tumor size. Of the responders, 66% responded within cycle 1. The median time to first response was 45 days (range 37–349 days). The median duration of response was 287 days, or 9.4 months (range 1–503 days). Thirteen of 109 evaluable patients had a duration of response ≥ 14 weeks (range 98–503 days). Clinical benefit such as improvement in progression free survival or overall survival has not been demonstrated.
Fotolyn is expected to be available in October 2009.
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