What is Vegzelma (bevacizumab-adcd)?
On September 28, the U.S. Food and Drug Administration (FDA) approved bevacizumab-adcd (Vegzelma), a biosimilar to bevacizumab (Avastin), for the treatment of six types of cancer: metastatic colorectal cancer; recurrent or metastatic nonsquamous nonāsmall cell lung cancer (NSCLC); recurrent glioblastoma; metastatic renal cell carcinoma; persistent, recurrent, or metastatic cervical cancer; and epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Where has Vegzelma (bevacizumab-adcd) been approved?
On September 28, the U.S. Food and Drug Administration (FDA) approved bevacizumab-adcd (Vegzelma), a biosimilar to bevacizumab (Avastin), for the treatment of six types of cancer: metastatic colorectal cancer; recurrent or metastatic nonsquamous nonāsmall cell lung cancer (NSCLC); recurrent glioblastoma; metastatic renal cell carcinoma; persistent, recurrent, or metastatic cervical cancer; and epithelial ovarian, fallopian tube, or primary peritoneal cancer.
The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Vegzelma has a highly similar structure, purity and biological activity to Avastin (an already EMA approved medicine) and is distributed in the body in the same way. The data were considered sufficient to conclude that Vegzelma will behave in the same way as Avastin in terms of effectiveness and safety in its authorised uses. Therefore, the Agencyās view was that, as for Avastin, the benefits of Vegzelma outweigh the identified risks and it can be authorised for use in the EU.
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