Vegzelma a New Biosimilar FDA Approved for the Treatment of 6 Types of Cancer

Web Exclusives - FDA Approvals

On September 28, 2022, the FDA approved bevacizumab-adcd (Vegzelma; Celltrion), a VEGF inhibitor and a biosimilar to bevacizumab (Avastin), for the treatment of metastatic colorectal cancer; recurrent or metastatic nonsquamous non–small-cell lung cancer (NSCLC); recurrent glioblastoma; metastatic renal-cell carcinoma; persistent, recurrent, or metastatic cervical cancer; and epithelial ovarian, fallopian tube, or primary peritoneal cancer. Bevacizumab-adcd is not indicated for the adjuvant treatment of colon cancer.

Bevacizumab-adcd is the fourth biosimilar to bevacizumab to be approved by the FDA. The approval was based on the totality of evidence showing no clinically meaningful differences in efficacy, safety, or pharmacokinetics between bevacizumab-adcd and the reference drug, including the results of a double-blind, randomized phase 3 clinical trial of 689 patients with metastatic or recurrent nonsquamous NSCLC.

In that study, the patients received 15 mg/kg of bevacizumab-adcd intravenously every 3 weeks for up to 6 cycles in the induction phase, followed by every 3 weeks until disease progression in the maintenance phase. The main end point was objective response at 21 weeks. The results showed that bevacizumab-adcd was highly similar to its reference drug in efficacy, safety, and pharmacokinetics.

The most common (>10%) adverse events with bevacizumab-adcd are epistaxis, headache, hypertension, rhinitis, proteinuria, taste alteration, dry skin, hemorrhage, lacrimation disorder, back pain, and exfoliative dermatitis.

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Last modified: October 31, 2022
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