FDA Approves Bevacizumab Biosimilar in Nonsquamous NSCLC
Posted: Tuesday, July 2, 2019
On June 28, the U.S. Food and Drug Administration (FDA) has approved a bevacizumab biosimilar, bevacizumab-bvzr (Zirabev). The drug has been approved for the treatment of recurrent or metastatic nonsquamous non–small cell lung cancer (NSCLC), as well as metastatic colorectal cancer; recurrent glioblastoma; metastatic renal cell carcinoma; and persistent, recurrent, or metastatic cervical cancer. This bevacizumab biosimilar was approved in the European Union in February 2019.
Supporting the approval of this biosimilar is data from the REFLECTIONS B7391003 study, a comparative, confirmatory safety and efficacy study of the biosimilar versus the reference bevacizumab. The trial enrolled 719 patients with advanced nonsquamous NSCLC. The study demonstrated equivalence in the primary endpoint of objective response rate of the biosimilar versus the reference bevacizumab when taken in combination with carboplatin/paclitaxel for first-line treatment of NSCLC.
