Pharma Focus Asia
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BioLineRx Receives FDA Approval of APHEXDA™ in Combination with Filgrastim (G-CSF)

Monday, September 11, 2023

BioLineRx has received FDA approval for its drug APHEXDA™ (motixafortide) in combination with filgrastim (G-CSF) to assist in mobilising haematopoietic stem cells for peripheral blood collection and subsequent autologous transplantation in patients with multiple myeloma. APHEXDA is administered through subcutaneous injection.

The approval of APHEXDA addresses the significant need for new therapies to provide more reliable stem cell mobilisation compared to using filgrastim alone. It offers the advantage of fewer days of aphaeresis sessions and reduces the number of filgrastim doses required for individuals living with multiple myeloma.

The FDA approval of APHEXDA is based on the promising results from the 2-part, Phase 3 GENESIS trial. This trial was a randomised, double-blind, placebo-controlled study that assessed the safety and efficacy of APHEXDA (motixafortide) in combination with filgrastim versus a placebo combined with filgrastim for the mobilisation of haematopoietic stem cells in multiple myeloma patients.

The strong efficacy data obtained from the GENESIS trial, which included patients representative of the current multiple myeloma population, suggests that APHEXDA will play a critical role in meeting unmet needs and potentially introduce a new treatment approach for this challenging cancer.

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