European committee recommends against Folotyn for PTCL

Submitted by Ross Bonander Sun 01/22/2012

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Allos Therapeutics has announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has made a recommendation against conditional approval of Allos' oncology product Folotyn (pralatrexate injection) for the treatment of patients with peripheral T-cell lymphoma (PTCL) whose disease has progressed after at least one prior systemic therapy.

Allos intends to appeal this by requesting a re-examination of the CHMP opinion within two weeks.

Said Charles Morris, chief medical officer at Allos Therapeutics. “We are committed to making Folotyn available in the EU for patients with relapsed or refractory peripheral T-cell lymphoma -- an aggressive and progressive disease where there remains a high unmet need for new therapies."

Folotyn is a folate analogue metabolic inhibitor. It was granted accelerated approval in 2009 by the US FDA for use as a single agent for the treatment of patients with relapsed or refractory PTCL.

Source: Allos Therapeutics

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