Pfizer Inc. announced the United States (U.S.) Food and Drug Administration(FDA) has approved Zirabev (bevacizumab-bvzr), a biosimilar to Avastin® (bevacizumab),1 for the treatment of five types of cancer: metastatic colorectal cancer; unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer (NSCLC); recurrent glioblastoma; metastatic renal cell carcinoma (RCC); and persistent, recurrent or metastatic cervical cancer.2
"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," said Andy Schmeltz, Global President, Pfizer Oncology. "We are proud to add Zirabev to our growing oncology portfolio for U.S. patients living with a wide variety of tumor types."
The FDA approval was based on review of a comprehensive data package which demonstrated biosimilarity of Zirabev to the reference product. This includes results from the REFLECTIONS B7391003 clinical comparative study, which showed clinical equivalence and found no clinically meaningful differences between Zirabev and the reference product in patients with advanced non-squamous NSCLC.3
"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.4 "The FDA’s approval of Zirabev may provide an important new option for the treatment of multiple forms of cancer."
Biosimilars have been a significant catalyst for change for the healthcare industry over the last decade, with the potential to create a more sustainable healthcare system. With more than 10 years of global in-market experience and six approved biosimilar products in the U.S., Pfizer is proud to be a leader and at the forefront of this vital healthcare segment. Zirabev is Pfizer’s second oncology monoclonal antibody (mAb) biosimilar to be approved by the FDA, following the FDA approval of TRAZIMERA™ (trastuzumab-qyyp) in March 2019.5 Zirabev was also approved for use in the European Union (EU) in February 2019 for the treatment of metastatic carcinoma of the colon or rectum, metastatic breast cancer, unresectable advanced, metastatic or recurrent NSCLC, advanced and/or metastatic RCC and persistent, recurrent or metastatic carcinoma of the cervix.6
About Zirabev (bevacizumab-bvzr)
Zirabev is a mAb biosimilar of the reference product, Avastin, which works by inhibiting the formation of new blood cells (angiogenesis) by specifically recognizing and binding to vascular endothelial growth factor (VEGF) protein. As part of the REFLECTIONS clinical trial program, Zirabev has been studied in nearly 400 patients to date.3,7,8,9
INDICATIONS
Metastatic Colorectal Cancer
Zirabev, in combination with intravenous fluorouracil-based chemotherapy, is indicated for the first- or second-line treatment of patients with metastatic colorectal cancer (mCRC).
Zirabev, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy, is indicated for the second-line treatment of patients with mCRC who have progressed on a first-line bevacizumab product-containing regimen.
Limitation of Use: Zirabev is not indicated for adjuvant treatment of colon cancer.
First-Line Non-Squamous Non-Small Cell Lung Cancer
Zirabev, in combination with carboplatin and paclitaxel, is indicated for the first line treatment of patients with unresectable, locally advanced, recurrent or metastatic non–squamous non–small cell lung cancer (NSCLC).
Recurrent Glioblastoma
Zirabev is indicated for the treatment of recurrent glioblastoma (GBM) in adults.
Metastatic Renal Cell Carcinoma
Zirabev, in combination with interferon alfa, is indicated for the treatment of metastatic renal cell carcinoma (mRCC).
Persistent, Recurrent, or Metastatic Cervical Cancer
Zirabev, in combination with paclitaxel and cisplatin or paclitax...
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