European committee recommends against Folotyn for PTCL


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 peripheral T-cell lymphoma (PTCL) in patients 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.

“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," said Charles Morris, chief medical officer at Allos Therapeutics.

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

Source: Allos Therapeutics

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