FDA Approves Avastin Biosimilar, Zirabev (Bvacizumab-bvzr), for Various Cancers

June 28, 2019

Bevacizumab-bvzr is an mAb endothelial growth factor biosimilar.

Pfizer’s Zirabev (bevacizumab-bvzr), an mAb biosimilar to Avastin, has been approved by the FDA to treat a variety of cancers, including metastatic colorectal cancer; unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer (NSCLC); recurrent glioblastoma in adults; metastatic renal cell carcinoma; and persistent, recurrent, or metastatic cervical cancer. 

Like its reference product, bevacizumab-bvzr is an endothelial growth factor inhibitor that works by inhibiting the formation of new blood cells by recognizing and binding specifically to vascular endothelial growth factor proteins. 

In a clinical study, researchers found no clinically meaningful differences between bevacizumab-bvzr and its reference product in patients with advanced nonsquamous NSCLC. 

“Biosimilars like ZIRABEV can help increase access to impactful therapies, driving market competition that may ultimately lower costs and help address the diverse needs of patients living with cancer,” says Andy Schmeltz, Global President of Pfizer Oncology in a prepared statement. “We are proud to add ZIRABEV to our growing oncology portfolio for U.S. patients living with a wide variety of tumor types.”

For patient with metastatic colorectal cancer, bevacizumab-bvzr is indicated in combination with fluorouracil-based chemotherapy for first- or second-line treatment, and in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen.

For patients with unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer, bevacizumab-bvzr in combination with carboplatin and paclitaxel for first-line treatment.

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For patients with metastatic renal cell carcinoma, bevacizumab-bvzr is indicated in combination with interferon alfa. 

For patients with persistent, recurrent, or metastatic cervical cancer, bevacizumab-bvzr is indicated in combination with paclitaxel and cisplatin or paclitaxel and topotecan. 

Bevacizumab-bvzr comes with a variety of warnings for healthcare professionals, including the development of gastrointestinal perforations and fistula, surgery and wound healing complications, hemorrhage, arterial and venous thromboembolic events, hypertension, renal injury and proteinuria, infusion-related reactions, embryo-fetal toxicity, ovarian failure, and congestive heart failure. 

The most common adverse events reported in all clinical trials including bevacizumab-bvzr include epistaxis, headache, hypertension, rhinitis, proteinuria, taste alteration, dry skin, rectal hemorrhage, lacrimation disorder, back pain and exfoliative dermatitis Across all studies, bevacizumab-bvzr was discontinued in 8% to 22% of patients due to adverse reactions, according to Pfizer’s prepared statement. 

 

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