Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Allos Therapeutics has signed an agreement with the US Food and Drug Administration (FDA) for the design o f Folotyn (pralatrexate injection) randomized, multi-center, international Phase 3 clinical trial evaluating patients with previously undiagnosed peripheral T-cell lymphoma (PTCL).
Subscribe to our email newsletter
The co-primary endpoints will be progression-free survival and overall survival and the company expects to commence this Phase 3 clinical trial of Folotyn in 2011.
Allos chief medical officer Charles Morris said this important study has the potential to support the conversion of the current accelerated approval in the US to a full approval and expand Folotyn’s indication to the first-line setting.
"The study further demonstrates our commitment to the medical community and patients to explore the full potential of Folotyn and improve outcomes for patients with PTCL," Morris said.