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September 11, 2023Sept. 11, 2023 - BioLineRx Ltd., a commercial stage biopharmaceutical company focused on certain cancers and rare diseases, has announced that the U.S. Food and Drug Administration has approved Aphexda™ (motixafortide) in combination with filgrastim (G-CSF). This functions to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma. Aphexda is administered by injection, for subcutaneous use.
Multiple myeloma is the second most-common hematologic malignancy. Autologous stem cell transplantation (ASCT) is part of the standard of care treatment paradigm for multiple myeloma and delivers prolonged survival for patients with this cancer type. The success of ASCT depends on adequate mobilization of stem cells during the treatment process. The American Society for Transplantation and Cellular Therapy (ASTCT) guidelines recommend a collection target of 3-5 x 10 CD34+ cells/kg. Additionally, collection of a sufficient number of stem cells to perform two transplantations is recommended. Historically, depending on induction regimens and mobilization strategies, up to 47% of patients have had challenges collecting target numbers of hematopoietic stem cells for ASCT after one apheresis session.
- Aphexda is the first innovation in stem cell mobilization for multiple myeloma to be approved in the U.S. in a decade.
- One dosage of Aphexda plus filgrastim enabled a majority of patients to achieve the collection goal of ≥ six million hematopoietic stem cells among a contemporary population of multiple myeloma patients.
Aphexda is contraindicated in patients with a history of serious hypersensitivity reactions to motixafortide.
Based on its mechanism of action, Aphexda can cause fetal harm.