Bevacizumab biosimilar gets FDA nod for 5 cancer types

  • FDA

  • curated by Jim Kling
  • Univadis Clinical Summaries
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Takeaway

  • The FDA has approved the biosimilar bevacizumab-bvzr for metastatic colorectal cancer (mCRC); unresectable, locally advanced, recurrent or metastatic nonsquamous NSCLC; recurrent glioblastoma; metastatic renal cell carcinoma (mRCC); and persistent recurrent or metastatic cervical cancer.

Why this matters

  • Bevacizumab-bvzr could offer a cheaper alternative to the reference product.

Key points

  • The approval was based on results from the REFLECTIONS B7391003 clinical comparative study in NSCLC (n=719, bevacizumab-bvzr vs bevacizumab). At week 19, the relative risk for objective response rate was within the FDA-specific therapeutic equivalence margin. There were similar frequencies of treatment-emergent adverse events.
  • Approved for mCRC:
    • First- or second-line treatment in combination with intravenous fluorouracil-based chemotherapy.
    • Second-line therapy after progression on a first-line bevacizumab product-containing regimen in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy.
    • Limitation of use: not indicated for adjuvant treatment of colon cancer.
  • Approved for first-line treatment of unresectable locally advanced, recurrent or metastatic NSCLC in combination with carboplatin and paclitaxel.
  • Approved for recurrent glioblastoma in adults.
  • Approved for mRCC in combination with interferon alpha.
  • Approval for persistent, recurrent, or metastatic cervical cancer in combination with paclitaxel and cisplatin or paclitaxel and topotecan.
  • Full prescribing information.