The U.S. Food and Drug Administration (FDA) has approved Pfizer’s Ruxience (rituximab-pvvr), a biosimilar to Rituxan (rituximab), for all non-Hodgkin’s lymphoma indications of its reference product, the company announced.
The therapy was also approved for people with chronic lymphocytic leukemia (CLL), as well as granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), two subtypes of the autoimmune condition ANCA-associated vasculitis.
This is the second Rituxan biosimilar approved in the United States, following the approval of Truxima (rituximab-abbs) in November 2018.
“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,” Jeff Sharman, medical director, US Oncology Hematology Research, said in a press release.
“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,” said Andy Schmeltz, global president, Pfizer oncology.
Biosimilars are biological medical products nearly identical to their original product, but manufactured by a different company after the original product’s patent expires. They usually are sold at significantly lower prices.
Unlike chemical compounds, which are made through chemical reactions, biological medicines are grown in cells and may show some differences from similarly designed products.
Thus, the FDA and other regulatory agencies require extensive data showing that a biosimilar has a similar behavior to the original medicine, not only in terms of effectiveness and safety, but also regarding the compound’s behavior — absorption, distribution, metabolism, and excretion — once inside the body.
Ruxience, like its original medicine Rituxan (sold in Europe as MabThera), is an antibody that targets the CD20 molecule found in healthy B-cells and lymphoma cells. By inhibiting the excessive growth and spread of B-cells, the treatment improves lymphoma symptoms.
Ruxience’s approval was based on a comprehensive analysis showing that it is similar to Rituxan in its chemical composition, biological behavior, and safety. Among the data submitted to the FDA, researchers included results from the REFLECTIONS B328-06 Phase 3 trial (NCT02213263), which compared Ruxience to Rituxan in a group of patients with CD20-positive, low-tumor burden follicular lymphoma, a type of non-Hodgkin’s lymphoma.
The trial included 394 patients who received either Ruxience or Rituxan as their initial treatment. The primary goal was to compare response rates after 26 weeks of treatment, but researchers also examined safety, time to disease worsening, rate of complete responses, and duration of responses as secondary measures.
Results showed no clinically meaningful differences in overall response rate between Ruxience (75.5%) and Rituxan (70.7%). Safety was also similar, such as the proportion of patients alive and progression-free at one year – 76.4% vs. 81.2%.
Based on the findings, the FDA approved Ruxience for six indications:
- As a single agent for low-grade or follicular, CD20-positive, B-cell non-Hodgkin’s lymphoma patients who have failed prior therapies;
- In combination with first-line chemotherapy for untreated follicular, CD20-positive, B-cell non-Hodgkin’s lymphoma patients, and alone as a maintenance therapy for patients who previously responded to rituximab;
- As a single agent for low-grade, CD20-positive, B-cell non-Hodgkin’s lymphoma patients who achieved at least stable disease after first-line chemotherapy containing clophosphamide, vincristine, and prednisone;
- In combination with chemotherapy for untreated CD20-positive diffuse large B-cell lymphoma;
- For either treated or untreated CD20-positive CLL, in combination with fludarabine and cyclophosphamide chemotherapies;
- In combination with glucocorticoids for GPA and MPA patients.
“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,” Sharman said.
Pfizer has also requested that Ruxience be approved in the European Union, an application that is under review by the European Medicines Agency.