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FDA Approves Bevacizumab Biosimilar

Gina Columbus @ginacolumbusonc
Published: Friday, Jun 28, 2019

The FDA has approved PF-06439535 (bevacizumab-bvzr; Zirabev), a bevacizumab (Avastin) biosimilar for the treatment of patients with metastatic carcinoma of the colon or rectum; unresectable advanced, metastatic, or recurrent non–small cell lung cancer (NSCLC); advanced and/or metastatic renal cell cancer, and persistent recurrent or metastatic carcinoma of the cervix.1

Treatment-related AEs were observed in 15.2% of those who received the biosimilar compared with 25.7% and 18.2% in those who were given bevacizumab-EU and bevacizumab-US, respectively.

References

  1. Pfizer. Pfizer Receives U.S. FDA Approval for Its Oncology Biosimilar, ZIRABEV (bevacizumab-bvzr). Published June 28, 2019. Accessed June 28, 2019.
  2. Socinski MA, Von Pawel J, Kasahara K, et al. A comparative clinical study of PF-06439535, a candidate bevacizumab biosimilar, and reference bevacizumab, in patients with advanced non-squamous non–small cell lung cancer. J Clin Oncol. 2018;36(suppl 15, abstr 109). doi: 10.1200/JCO.2018,36,15_suppl.109.
  3. Knight B, Rassam D, Liao S, et al. A phase I pharmacokinetics study comparing PF-06439535 (a potential biosimilar) with bevacizumab in healthy male volunteers. Cancer Chemother Pharmacol. 2016;77(4):839-46. doi: 10.1007/s00280-016-3001-2.

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