European committee upholds negative opinion of Folotyn


Allos Therapeutics, developers of Folotyn (pralatrexate injection), announced some bad news from European regulators.

Allos had requested that the European Medicines Agency's Committee For Medicinal Products for Human Use (CHMP) to reconsider and re-examine its negative opinion on the company's seeking marketing authorization application (MAA) for Folotyn in Europe as a treatment for patients with peripheral T-cell lymphoma (PTCL) whose disease has progressed after at least one prior systemic therapy.

Hoping they would change their minds and therefore their opinion, Allos was disappointed to be told that after reconsideration, the CHMP merely confirmed its previous negative opinion on the drug.

"We are very disappointed with the CHMP opinion on the MAA for Folotyn in Europe," said Charles Morris, MB ChB, MRCP, chief medical officer at Allos Therapeutics. "We will continue to ... pursue regulatory approval to market Folotyn for relapsed or refractory PTCL in other countries, and to evaluate our options for bringing Folotyn to patients who could benefit from it in Europe. We also remain fully committed to advancing the Folotyn development program in hematologic malignancies, including first-line PTCL and relapsed or refractory cutaneous T-cell lymphoma."

Folotyn was given accelerated approval by the US FDA in 2009 as a single-agent for the treatment of relapsed or refractory PTCL.

Allos was recently acquired through merger by Spectrum Pharmaceuticals, makers of Zevalin, a treatment for indolent non-Hodgkin's lymphomas.

Source: MarketWatch

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