Ruxience, a monoclonal antibody (mAb), has been approved to treat non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukaemia (CLL), and granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA).
Ruxience works by targeting a CD20 protein, which is present on the surface of B cells. Rituximab enables to destroy the B cells when it attaches to CD20.
Pfizer Oncology global president Andy Schmeltz said: “Biosimilars like RUXIENCE have the potential to deliver real value in healthcare, improving access to and affordability of an important cancer treatment which could help more patients receive optimal care.
“The FDA approval marks our third oncology biosimilar to be approved in the U.S. this year, reinforcing our commitment to bring these important medicines to patients living with cancer.”
The approval was based on results from a comprehensive data package, which showed biosimilarity of Ruxience to the reference product.
The Reflections B3281006 clinical comparative study assessed the efficacy, safety, and immunogenicity, pharmacokinetics and pharmacodynamics of Ruxience and demonstrated no clinically meaningful differences in safety or efficacy compared to the reference product in patients with CD20-positive, low tumour burden follicular lymphoma.
US Oncology Hematology Research medical director Dr Jeff Sharman said: “Rituximab became one of the first monoclonal antibody (mAb) cancer treatments when it was initially approved by the FDA, representing a significant treatment advance and the only option available to oncologists and their patients for a period of time.
“With this FDA approval, clinicians have an additional treatment option that will help improve access to care for patients in need of anti-CD20 mAb therapy.”
Earlier this month, Pfizer secured FDA approval for its Zirabev (bevacizumab-bvzr), an oncology biosimilar to Roche’s Avastin (bevacizumab).
Zirabev was approved to treat five types of cancer, including metastatic colorectal cancer; unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer (NSCLC), recurrent glioblastoma; metastatic renal cell carcinoma (RCC) and persistent, recurrent or metastatic cervical cancer.