BioLineRx Ltd. (BLRX), a commercial stage biopharmaceutical company focused on certain cancers and rare diseases, announced Monday that the U.S. Food and Drug Administration or FDA has approved APHEXDA (motixafortide) in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood. This is for collection and subsequent autologous transplantation in patients with multiple myeloma.
In pre-market activity on Nasdaq, the shares were gaining around 29 percent.
APHEXDA is administered by injection, for subcutaneous use. It is the first innovation in stem cell mobilization for multiple myeloma to be approved in the U.S. in a decade. BioLineRx expects to make APHEXDA available later this month.
For Multiple myeloma, a hematologic malignancy, autologous stem cell transplantation or ASCT is part of the standard of care treatment paradigm 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 FDA approval of APHEXDA is based on results from the 2-part, Phase 3 GENESIS trial, a randomized, double-blind, placebo-controlled study. The trial evaluated the safety and efficacy of APHEXDA plus filgrastim, compared to placebo plus filgrastim, for the mobilization of hematopoietic stem cells for autologous transplantation in multiple myeloma patients.
The company noted that one dosage of APHEXDA plus filgrastim enabled a majority of patients to achieve the collection goal of = 6 million hematopoietic stem cells among multiple myeloma patients.
In pre-market activity on Nasdaq, the shares were trading at $2.69, up 28.71 percent.
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