In May 2012, Pixuvri received conditional marketing authorization in the EU as monotherapy for the treatment of adult patients with multiply-relapsed or refractory aggressive NHL. The benefit of Pixuvri treatment has not been established in patients when used as fifth line or greater chemotherapy in patients who are refractory to last therapy. The Summary of Product Characteristics ("SmPC") has the full prescribing information, including the safety and efficacy profile of Pixuvri in the approved indication. The SmPC is available at http://ec.europa.eu/health/documents/community-register/html/h764.htm#ProcList.
CTI is currently accruing patients into a Phase III trial comparing pixantrone and rituximab with gemcitabine and rituxan in the setting of aggressive B-cell Non-Hodgkin Lymphoma. European sites will be participating in this study later this year.
Pixuvri is currently available in the EU through Named Patient Programs.
Pixuvri does not have marketing approval in the United States.About Conditional Marketing Authorization Similar to accelerated approval regulations in the United States, conditional marketing authorizations are granted in the EU to medicinal products with a positive benefit/risk assessment that address unmet medical needs and whose availability would result in a significant public health benefit. A conditional marketing authorization is renewable annually. Under the provisions of the conditional marketing authorization for Pixuvri, CTI will be required to complete a post-marketing study aimed at confirming the clinical benefit previously observed. The European Medicines Agency's (the "EMA") Committee for Medicinal Products for Human Use ("CHMP") has accepted PIX306, CTI's ongoing randomized controlled phase 3 clinical trial, which compares Pixuvri-rituximab to gemcitabine-rituximab in patients who have relapsed after one to three prior regimens for aggressive B‑cell NHL and who are not eligible for autologous stem cell transplant. As a condition of approval, CTI has agreed to have available the PIX306 clinical trial results by June 2015. About Pacritinib Pacritinib is an oral, once a day, tyrosine kinase inhibitor (TKI) with dual activity against JAK2 and FMS-like tyrosine kinase 3 ("FLT3"). Mutations in these kinases have been shown to be directly related to the development of a variety of blood related cancers including MPN, leukemia, and lymphoma. Pacritinib has demonstrated encouraging results in phase I and II studies for patients with myelofibrosis and a phase III study is planned for this disease. FLT3 is a commonly mutated gene found in acute myeloid leukemia ("AML") patients and its activating mutations have been proven to be a negative prognostic marker for clinical outcome suggesting a possible future role for treatment of AML.