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

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.

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!