Allos Thera questions CHMP Folotyn decision; posts new data

USA-based Allos Therapeutics, Inc. (Nasdaq: ALTH) says that it has submitted a request to the European Medicines Agency for a re-examination of the negative opinion issued in January by the EMA’s Committee For Medicinal Products for Human Use (CHMP) for conditional approval of 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.

PTCL comprises a biologically diverse group of aggressive, rare blood cancers that have a worse prognosis than most other types of lymphoma, including B-cell lymphoma. According to current CHMP guidelines, a final opinion on the re-examination could be issued by the EMA within four to five months.

On January 20, the CHMP recommended against the approval Folotyn. The drug is approved in the US as a treatment for peripheral T-cell lymphoma in patients who have suffered a relapse or who have not responded to previous treatment (The Pharma Letter September 28, 2009). Pralatrexate has orphan medicinal product designation in Europe for the treatment of PTCL (nodal, other extranodal, and leukemic/disseminated).