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EU approves Aybintio for carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube and peritoneal cancer and cervical cancer.- Samsung Bioepis
Samsung Bioepis announced that the European Commission (EC) has granted marketing authorization for Aybintio (bevacizumab biosimilar) for the treatment of the same types of cancer as reference bevacizumab, including metastatic carcinoma of the colon or rectum (mCRC), metastatic breast cancer (mBC), non-small cell lung cancer (NSCLC), advanced and/or metastatic renal cell cancer (mRCC), epithelial ovarian, fallopian tube and primary peritoneal cancer and cervical cancer.
EC approval was supported by a comprehensive data package and totality of evidence which included analytical, pharmacokinetic (PK) and clinical data, as well as pharmacology and toxicology data. This data demonstrated that Aybintio and reference bevacizumab are highly similar with no clinically meaningful differences.
Condition: Non Small Cell Lung Cancer
Type: drug