- 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.
- 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.