FDA Approves Avastin Biosimilar to Treat Six Diseases Including Certain Colon, Lung, Kidney Cancers

The FDA’s approval of Vegzelma was based on data that demonstrated the biosimilar elicited comparable safety and efficacy to Avastin in several studies.

The Food and Drug Administration (FDA) approved the biosimilar Vegzelma (bevacizumab-adcd) for the treatment of six cancer types including recurrent or metastatic non-squamous non-small cell lung cancer, metastatic colorectal cancer and metastatic renal cell carcinoma, among others, according to an announcement from the drug’s manufacturer.

The anticancer monoclonal antibody Vegzelma, which is also for the treatment of recurrent glioblastoma (an aggressive type of cancer that occurs in the brain or spinal cord); epithelial ovarian, fallopian tube or primary peritoneal cancer; and persistent, recurrent or metastatic cervical cancer, is similar to Avastin (bevacizumab), according to a press release from Celltrion USA, the manufacturer of Vegzelma.

“Biosimilars have been used in many disease areas including oncology, and have been shown to be safe and effective while lowering the drug cost and increasing the access to more patients around the world,” said Dr. Claire Verschraegen, director of the Division of Medical Oncology at the Ohio State University Comprehensive Cancer Center in Columbus, in the release. “With the availability of biosimilars such as Vegzelma in the U.S., oncologists will have additional treatment options for patients across multiple cancer types.”

This FDA approval was based on findings from several studies including a phase 3 trial of patients with recurrent or metastatic non-squamous non-small cell lung cancer, according to the release. In particular, results demonstrated that first-line treatment with Vegzelma was similar to Avastin in regard to safety, efficacy and pharmacokinetics (the way a drug is processed by the body).

“The approval of Vegzelma is an important milestone in the U.S., … and marks an important step forward in expanding access to cancer care,” said Jaeik Shim, chief operating officer at Celltrion USA, in the release.

The most frequently observed side effects associated with Vegzelma, occurring in at least 10% of patients, include headache, nose bleeds, stuffy nose, high blood pressure, taste alteration, protein in urine, bleeding, dry skin, back pain, excessive tearing from the eyes and extreme shedding of the top layers of skin, according to the release.

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