You are here

FDA Approves Pegfilgrastim Biosimilar for Cancer

New Drug Reduces Infection in Chemotherapy Patients

The FDA has approved Udenyca (pegfilgrastim-cbqv, Coherus BioSciences, Redwood City, California) for patients with cancer who are receiving myelosuppressive chemotherapy. Pegfilgrastim-cbqv is a leukocyte growth factor designed to reduce infections as indicated by febrile neutropenia.

The drug is contraindicated for patients who have a history of serious allergic reaction to human granulocyte colony-stimulating factors and is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

The most common adverse reactions associated with pegfilgrastim-cbqv are bone pain and pain in extremities.

Pegfilgrastim-cbqv is Coherus’ first drug to receive approval from the FDA and has also been approved for use in Europe after receiving a favorable response from the European Medicines Agency’s Committee for Human Use in July of this year.

Source: GlobeNewswire, November 5, 2018; Healio.com, November 5, 2018

Recent Headlines

Citrus, Berries, Broccoli Reduce Risk of Cancer and CVD
Changes in Antibiotic Recommendations for Children
Influences Gene Involved in Circadian Rhythms
‘The Perfect Drug for Trauma-Focused Psychotherapy’
Triggers the Body’s Own Natural Blood Flow Regulation
Inrebic Reduces Symptoms by 50% in Some Patients
Novel Catheter-based Technology for Treating Acute Ischemic Stroke
Decision supported by data from more than 4,000 patients