Allos (ALTH) Says CHMP Reaffirms Negative Opinion on FOLOTYN MAA
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Allos Therapeutics, Inc. (Nasdaq: ALTH) reports that following its request for re-examination, the European Medicines Agency’s Committee For Medicinal Products for Human Use (CHMP) confirmed its previous negative opinion on the marketing authorisation application (MAA) for FOLOTYN (pralatrexate injection) as a treatment for patients with peripheral T-cell lymphoma (PTCL) whose disease has progressed after at least one prior systemic therapy. Allos intends to review the CHMP opinion and evaluate its potential options for continuing to pursue regulatory approval of FOLOTYN in Europe for this indication.
“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 work closely with our partner Mundipharma 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.”
“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 work closely with our partner Mundipharma 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.”
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