The treatment is intended for mobilising haematopoietic stem cells to peripheral blood. Credit: Terelyuk/Shutterstock.com.

BioLineRx has received US Food and Drug Administration (FDA) approval for Aphexda (motixafortide) plus filgrastim (G-CSF) to mobilise haematopoietic stem cells to the peripheral blood for collection and autologous transplantation subsequently in multiple myeloma patients.

Intended for use as a subcutaneous injection, Aphexda is the first product for stem cell mobilisation in multiple myeloma to obtain approval in the region in the past ten years.

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BioLineRx plans to offer Aphexda in the country later this month.

The latest approval is based on data from the two-part, placebo-controlled, randomised, double-blind Phase III GENESIS clinical trial.

The trial analysed the efficacy and safety of Aphexda plus filgrastim versus placebo plus filgrastim.

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Findings showed that the combination treatment aided 67.5% of the trial subjects to attain the stem cell collection goal of ≥ 6 × 106 CD34+ cells/kg in two apheresis sittings compared with 9.5% in the placebo arm.

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Serious adverse reactions were reported in 5.4% of the trial participants in the Aphexda arm.

BioLineRx CEO Philip Serlin said: “Given the strong efficacy data shown in the GENESIS trial, which included patients who are representative of the current multiple myeloma patient population, we believe Aphexda will play a critical role in addressing unmet needs and introducing a new treatment paradigm for this challenging cancer. 

“The company is working relentlessly to make this important innovation in stem cell mobilisation available to appropriate patients, their physicians and transplant teams.”