Biosimilar Zirabev Gets FDA Approval for 5 Types of Cancer

The FDA has approved Zirabev (bevacizumab-bvzr; Pfizer), a biosimilar to Avastin (bevacizumab; Genentech).

The Food and Drug Administration (FDA) has approved Zirabev (bevacizumab-bvzr; Pfizer), a biosimilar to Avastin (bevacizumab; Genentech).

Zirabev, a vascular endothelial growth factor (VEGF) inhibitor, is indicated for first- or second-line treatment of metastatic colorectal cancer (mCRC) as part of a treatment regimen with intravenous (IV) fluorouracil; or as second-line treatment of mCRC, as part of a treatment regimen with fluoropyrimidine-irinotecan or fluoropyrimidine-oxaliplatin, in patients who have progressed on a first-line bevacizumab product-containing regimen.

In addition, it is approved for use in combination with carboplatin and paclitaxel for first-line treatment of unresectable, locally advanced, recurrent or metastatic non–squamous non–small cell lung cancer (NSCLC).

Zirabev is also approved for the treatment of: recurrent glioblastoma in adult patients; metastatic renal cell carcinoma, in combination with interferon alfa; and persistent, recurrent, or metastatic cervical cancer, in combination with paclitaxel-cisplatin or paclitaxel-topotecan.

The approval was based on a review of data which demonstrated the biosimilarity of Zirabev to the reference product. The data package included results from the REFLECTIONS (B7391003) study which found the biosimilar to be comparable to the reference product in patients with advanced non-squamous NSCLC. 

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“Zirabev represents a welcome addition to the treatment armamentarium in its approved indications, potentially providing physicians with a medicine that has a similar safety profile and efficacy as the reference product,” said Dr Niels Reinmuth, Department of Thoracic Oncology, Asklepios Lung Clinic, Munich-Gauting, Germany and lead author of the REFLECTIONS B7391003 study. “The FDA’s approval of Zirabev may provide an important new option for the treatment of multiple forms of cancer.”

Regarding safety, the most common treatment-emergent adverse events (>10%) were epistaxis, headache, hypertension, rhinitis, proteinuria, taste alteration, dry skin, rectal hemorrhage, lacrimation disorder, back pain, and exfoliative dermatitis.

Zirabev will be supplied in single-dose vials in 100mg/4mL and 400mg/16mL strengths.

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