In late September 2022, Healio reported that the U.S. Food and Drug Administration (FDA) approved bevacizumab-adcd (Vegzelma), a biosimilar of Genentech’s bevacizumab (Avastin). The approval of biosimilars such as this can help patients by providing effective care, increasing access to therapeutics, and lowering prices.
In this case, Vegzelma has the potential to fill an unmet need for many patients, or to provide first-line treatment options to those in need.
This approval covers six different oncologic indications:
- Metastatic renal cell carcinoma (RCC)
- Epithelial ovarian, fallopian tube, or primary peritoneal cancer
- Metastatic colorectal cancer
- Persistent, recurrent, or metastatic cervical cancer
- Recurrent glioblastoma
- Metastatic or recurrent nonsquamous non-small cell lung cancer (NSCLC)
The approval hinged on data that was sourced from a Phase 3 study which highlighted Vegzelma as beneficial for patients with non-small cell lung cancer. Data from the study found that Vegzelma was similar to Avastin in terms of safety, efficacy, tolerability, and pharmacokinetics.
What is Vegzelma?
Celltrion describes Vegzelma as:
an anti-cancer monoclonal antibody treatment [which] binds to vascular endothelial growth factor (VEGF), the key driver of vasculogenesis and angiogenesis, and thereby inhibits the binding of VEGF to its receptors Flt-1 and kinase insert domain receptor (KDR) on the surface of endothelial cells.
While Vegzelma is relatively safe and well-tolerated, certain side effects have been both reported and observed during trials. These include:
- Nosebleeds
- Skin dryness
- Changes in taste
- Proteinuria (excess protein in the urine)
- High blood pressure
- Stuffy nose
- Headaches
- Back pain
- Hemorrhage
- Lacrimation disorder
- Note: Lacrimation refers to excessive tearing or “crocodile tears,” in which someone may tear up and leak.
Vegzelma is already approved for a number of indications in the European Union. In addition to the six named conditions above, Vegzelma is also approved in the EU for the treatment of metastatic breast cancer when used in conjunction with paclitaxel or capecitabine.
