On September 28, 2022, the FDA approved Vegzelma (bevacizumab-adcd; from Celltrion), a VEGF inhibitor and a biosimilar to Avastin (bevacizumab), for the treatment of 6 types of cancer, including metastatic (spreading) colorectal cancer; recurrent (coming back) or metastatic nonsquamous non–small-cell lung cancer; recurrent glioblastoma (a type of brain cancer); metastatic kidney cancer; persistent, recurrent, or metastatic cervical cancer; and several types of ovarian cancer.
A biosimilar is a drug that is very similar in its effectiveness and safety to a previously approved drug, but it is sold for less money, because it takes less time and less research to manufacture the biosimilar compared with the original drug. Vegzelma is the fourth biosimilar to Avastin to be approved by the FDA.
“Biosimilars have been…shown to be safe and effective, while lowering the drug cost and increasing the access to more patients around the world,” said Claire Verschraegen, MD, MS, FACP, Director of the Division of Medical Oncology, Ohio State University Comprehensive Cancer Center in Columbus.
The FDA approved this new biosimilar based on evidence showing no clinically meaningful differences in effectiveness, safety, or pharmacokinetics between Vegzelma and Avastin; this included results from a randomized phase 3 clinical trial of 689 patients with metastatic or recurrent nonsquamous non–small-cell lung cancer, the most common type of lung cancer.
After 21 weeks of treatment with Vegzelma, the study results showed that Vegzelma was highly similar to Avastin in its efficacy, safety, and pharmacokinetics.
The most common side effects reported in 10% or more of the patients receiving Vegzelma are nose bleeding, headache, hypertension, rhinitis, proteinuria, change in taste, dry skin, bleeding, excessive tearing, back pain, and exfoliative dermatitis.
