FDA Approves Mvasi, First Oncology Biosimilar

September 14, 2017

Biosimilars Team

The Food and Drug Administration (FDA) has approved the vascular endothelial growth factor-specific angiogenesis inhibitor Mvasi (bevacizumab-awwb; Amgen, Inc.) as a biosimilar to Avastin (bevacizumab; Genentech, Inc.). Mvasi is the first biosimilar approved in the United States for the treatment of cancer.

Mvasi is administered by intravenous infusion. It is approved for the treatment of the following types of cancers in adult patients:

  • Metastatic colorectal cancer, in combination with intravenous 5-fluorouracil-based chemotherapy for first-line or second-line treatment. Mvasi is not indicated for the adjuvant treatment of surgically resected colorectal cancer.
  • Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan-based therapy or fluoropyrmidine-oxaliplatin-based chemotherapy for the second-line treatment of patients who have progressed on a first-line bevacizumab product-containing regimen. Mvasi is not indicated for the adjuvant treatment of surgically resected colorectal cancer.
  • Non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel, for first line treatment of unresectable, locally advanced, recurrent or metastatic disease.
  • Glioblastoma with progressive disease following prior therapy, based on improvement in objective response rate. No data is available demonstrating improvement in disease-related symptoms or survival with bevacizumab products.
  • Metastatic renal cell carcinoma, in combination with interferon alfa.
  • Cervical cancer that is persistent, recurrent, or metastatic, in combination with paclitaxel and cisplatin or paclitaxel and topotecan.

Mvasi is not approved as an interchangeable product.

Like Avastin, the labeling for Mvasi contains a Boxed Warning to alert health care professionals and patients about an increased risk of gastrointestinal perforations; surgery and wound healing complications; and severe or fatal pulmonary, gastrointestinal, central nervous system, and vaginal bleeding (hemorrhage). Patients should stop using Mvasi if gastrointestinal perforation occurs. Patients should not take Mvasi in the 28 days before and after elective surgery, and until the surgical wound is fully healed. Patients should stop using Mvasi if a surgical incision breaks open (wound dehiscence). Mvasi should not be given to patients with severe hemorrhage or in patients who cough up blood (hemoptysis).