Berlin and Würzburg, Germany, August 26, 2024 – Pentixapharm Holding AG announced that the European Medicines Agency (EMA) and the European Commission (EC) have granted orphan drug designation to the diagnostic tracer PentixaFor. The tracer, known as Gallium (68Ga) boclatixafortide, is used for the diagnosis and staging of marginal zone lymphoma (MZL).
Marginal zone lymphoma is a type of non-Hodgkin lymphoma recognized as a chronic, debilitating and life-threatening disease. Pentixapharm is sponsoring a European Phase III clinical trial to evaluate the performance of PentixaFor in imaging and staging patients with MZL.
PentixaFor is a novel PET imaging tracer targeting CXC receptor 4 (CXCR4), which is prevalent in MZL cells. Studies have shown that PentixaFor has high sensitivity and specificity for the diagnosis and staging of MZL, potentially surpassing the current standard [18F]FDG.
The European Orphan Drug Programme supports the development of medicines for rare diseases (affecting fewer than 5 in 10,000 people). Benefits include advice on EMA protocols, waivers of regulatory fees and possible market exclusivity for 10 years after approval.
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