FDA to Review Aphexda in the Transplant Setting for Patients with Multiple Myeloma

Aphexda was well tolerated and helped the majority of patients collect enough cells to go to transplant, study results showed.

The U.S. Food and Drug Administration has accepted a New Drug Application for Aphexda (motixafortide) in stem cell mobilization — a process by which stem cells are moved from the bone marrow to the blood — for autologous transplant in patients with multiple myeloma, according to a press release.

The application is based off results from the phase 3 GENESIS trial which met all of its goals, according to the release.

The trial compared Aphexda combined with granulocyte colony-stimulating factor (G-CSF) with placebo plus G-CSF in stem cell mobilization for autologous transplantation in patients with multiple myeloma. The Aphexda combination was also found to be safe and well tolerated.

"Aphexda has the potential to significantly improve outcomes and treatment experiences for patients with multiple myeloma, and the acceptance of our (New Drug Application) brings us closer to this important goal," said Philip Serlin, Chief Executive Officer of BioLineRx, the drug’s manufacturer, in the release.

An autologous stem cell transplant is a procedure which uses healthy blood stem cells from a patient’s body to replace the diseased bone marrow. It is a standard part of treatment for many different blood cancers, including multiple myeloma with 15,000 procedures performed each year.

Patients with multiple myeloma need to secure the necessary amount of stem cells to continue their treatment, as there is a trend of more aggressive induction protocols into treatment, according to the release, highlighting the importance of this New Drug Application.

"The clinical outcomes demonstrated by our GENESIS phase 3 study showed that nearly 90% of patients collected an optimal number of cells for transplantation following a single administration of Aphexda and in only one apheresis (cell collection) session,” Serlin added. “We believe Aphexda can become the standard of care in the multiple myeloma transplant setting, while also substantially decreasing healthcare resource utilization across a number of important areas."


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