FDA Approves First Biosimilar to Rituxan & New Drug for AML

On November 28, 2018, the U.S. Food and Drug Administration (FDA) approved two new products that affect the blood cancer community: Truxima® (rituximab-abbs) and Xospata® (gilteritinib). Truxima is approved to treat CD20-positive, B-cell non-Hodgkin’s lymphoma (NHL). Xospata is approved to treat adults with relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation.1,2

About Truxima

Truxima is the first biosimilar to Rituxan® (rituximab). A biosimilar is a product that is highly similar to an already approved product.1 Unlike generics, which have the same active ingredient and are equivalent copies of a reference medicine, biosimilars aren’t exactly like their reference product. However, biosimilars must undergo thorough evaluation to ensure their safety and effectiveness before they receive approval, demonstrating no clinically meaningful differences from the approved reference product.

Truxima may be used in certain cases as a single agent (the only treatment given), or it may be used in combination with other chemotherapy drugs. It is indicated to be used as a treatment for: 1

  • Relapsed or refractory CD20-positive B-cell NHL that is low grade or follicular, as a single agent
  • Previously untreated follicular, CD20-positive B-cell NHL in combination with chemotherapy
  • Maintenance therapy for people with follicular, CD20-positive B-cell NHL who have achieved a complete or partial response to a rituximab product, as a single agent
  • Non-progressing or stable low-grade, CD20-positive B-cell NHL as a single agent after chemotherapy with cyclophosphamide, vincristine, and prednisone (CVP)

Possible side effects of Truxima

The most common side effects experienced by patients in clinical trials receiving Truxima included infusion reactions, fever, low white blood cell counts, chills, infection, and weakness or lack of energy.1

About Xospata

Xospata is an oral medication for people with AML who have the FLT3 mutation, as identified by an approved genetic test.2 The presence of an FLT3 mutation is associated with worse outcomes for patients.3 Having a new medication to specifically target this type of AML offers new hope for patients.

Possible side effects of Xospata

The most common side effects experienced by patients in clinical trials receiving Xospata included muscle and joint pain, increase in liver enzymes (transaminase), fatigue, fever, noninfectious diarrhea, shortness of breath, swelling (edema), rash, pneumonia, nausea, inflammation or sores in the mouth, cough, headache, low blood pressure, dizziness and vomiting.2

View References
  1. FDA approves Truxima as biosimilar to Rituxan for non-Hodgkin’s lymphoma. U.S. Food and Drug Administration. Available at https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm627035.htm. Accessed 11/29/18.
  2. FDA approves gilteritinib for relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation. U.S. Food and Drug Administration. Available at https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm627045.htm. Accessed 11/29/18.
  3. Arber DA, Borowitz MJ, Cessna M, et al. Initial diagnostic workup of acute leukemia: guideline from the College of American Pathologists and the American Society of Hematology. Arch Pathol Lab Med. 2017;141:1342-1393. doi: 10.5858/arpa.2016-0504-CP.