Vegzelma is said to provide a new, safe, and effective treatment option for Europeans living with certain types of breast, lung, renal, colon, rectum, ovarian and cervical cancers, an affordable price
EC approves Celltrion’s Vegzelma. (Credit: Myriams-Fotos from Pixabay)
Celltrion Healthcare has received the European Commission (EC) approval for Vegzelma (CT-P16), its biosimilar product to Roche’s cancer drug bevacizumab.
The European regulator indicated Vegzelma for the treatment of multiple cancer types, including breast, lung, renal cell, colon or rectum, ovarian and cervical cancers.
Vegzelma is a recombinant humanised monoclonal antibody that binds to vascular endothelial growth factor (VEGF), inhibiting its receptors Flt-1 (VEGFR-1), and kinase insert domain receptor (KDR) (VEGFR-2).
The drug works by neutralising the biological activity of VEGF, to regress the vascularisation of tumours, normalise the remaining vasculature, and inhibit new tumour vasculature.
The South Korean biopharmaceutical company will offer Vegzelma 25mg/ml in Europe, for infusion under the supervision of an experienced physician.
Celltrion Healthcare senior vice president and marketing division head Kevin Byoung Seo Choi said: “The European Commission’s approval of Vegzelma will increase access to treatment for patients living with certain types of cancer at an affordable price.
“With proven similarities in efficacy and safety compared to the reference product Avastin, Vegzelma will be available to treat some of the most commonly diagnosed cancers, which collectively affect hundreds of thousands of European patients each year.”
The EC approval follows the positive opinion from the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP), granted in June this year.
The European regulator approved Vegzelma based on positive data, including the Phase 3 trial in patients with metastatic or recurrent non-squamous non-small cell lung cancer.
In the study Vegzelma, as a first-line treatment, showed that highly similar to the reference product in terms of efficacy, safety and pharmacokinetics.
Vegzelma marks the Celltrion’s third oncology biosimilar to get regulatory approval in the EU, following Truxima, a biosimilar to rituximab, and Herzuma, a biosimilar to trastuzumab.
The company has also submitted Vegzelma data to the US Food and Drug Administration (FDA) in September last year, and the approval is expected the third quarter this year.