BRIEF—Health Canada approval for Servier's Folotyn

Health Canada has granted a Notice of Compliance with conditions (NOCc) for Folotyn (pralatrexate) for the treatment of relapsed or refractory peripheral T-cell lymphoma (PTCL) from French privately held drugmaker Servier.

"We are very happy that Folotyn is now available in Canada, offering a novel treatment option for patients with Peripheral T-cell Lymphoma"said Elizabeth Lye, scientific advisor at Lymphoma Canada.

"PTCL is a subtype of lymphoma with a very poor prognosis, limited survival and few treatment options. Folotyn will change the treatment landscape for PTCL patients," she added.

Folotyn has a unique mechanism of action. It is a folate analog inhibitor depleting essential biological molecules leading to cancer growth inhibition and tumor cell death.

The efficacy and safety of Folotyn was evaluated in PROPEL, an international multicenter Phase II study, that enrolled 115 patients with relapsed or refractory PTCL.

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.