Posted by Michael Wonder on 02 Nov 2018
Servier receives Health Canada approval of Folotyn for the treatment of relapsed or refractory peripheral T-cell lymphoma
1 November 2018 - Servier Canada announced that Health Canada granted a Notice of Compliance with conditions for Folotyn (pralatrexate) for the treatment of relapsed or refractory peripheral T-cell lymphoma.
The efficacy and safety of Folotyn was evaluated in PROPEL, an international multi-centre Phase II study, that enrolled 115 patients with relapsed or refractory peripheral T-cell lymphoma. In this study, Folotyn was administered once weekly at a dose of 30mg/m2 for 6 weeks in 7-week cycles until progressive disease or unacceptable toxicity. Results of the PROPEL trial were published in the Journal of Clinical Oncology.
