FDA Approves Vegzelma, a Biosimilar to Bevacizumab, for Six Types of CancerFDA Approves Vegzelma, a Biosimilar to Bevacizumab, for Six Types of Cancer

 | Post date: 2022/09/13 | 

By PPN News Staff
The FDA has approved bevacizumab-adcd (Vegzelma, Celltrion USA), a biosimilar to bevacizumab (Avastin, Amgen), for the treatment of metastatic colorectal cancer; recurrent or metastatic non-squamous non-small cell lung cancer (nsNSCLC); recurrent glioblastoma; metastatic renal cell carcinoma; persistent, recurrent or metastatic cervical cancer; and epithelial ovarian, fallopian tube or primary peritoneal cancer.

“Biosimilars have been used in many disease areas, including oncology, and have shown to be safe and effective while lowering the drug cost and increasing the access to more patients around the world,” said Professor Claire Verschraegen, the director of the Division of Medical Oncology at The Ohio State University Comprehensive Cancer Center, in Columbus, in a Celltrion press release. “With the availability of biosimilars such as Vegzelma in the U.S., oncologists will have additional treatment options for patients across multiple cancer types.”

The approval of bevacizumab-adcd was based on the totality of evidence, including a pivotal phase 3 trial in patients with metastatic or recurrent nsNSCLC presented at the 2022 annual meeting of the American Association for Cancer Research, in New Orleans. 

In the phase 3 trial, patients were randomly assigned (1:1) to receive bevacizumab-adcd or bevacizumab with carboplatin-paclitaxel for up to 18 weeks (six cycles), followed by up to 24 weeks (eight cycles) of bevacizumab monotherapy.

The primary objective was to examine overall response rate (ORR) during the first 18 weeks. A total of 671 patients were included in the intent-to-treat population. The ratio of ORR was 0.96 (95% CI, 0.83-1.12) and the difference in ORR was −1.6 (95% CI, −9.0 to 5.9) between treatment arms. The confidence intervals were within the predefined equivalence margins. 

The results showed “that as a first-line treatment, bevacizumab-adcd is highly similar to the reference product in terms of efficacy, safety and pharmacokinetics,” the Celltrion press release stated.

Overall, the incidence of treatment-related adverse events and serious adverse events was comparable. Treatment-related anti-drug antibody (ADA) positivity was transient, with no notable differences between treatment arms (bevacizumab-adcd, 6.5%; bevacizumab, 4.8%). 

The incidence of neutralizing antibody post-baseline was lower in the bevacizumab-adcd arm (0.6%) than the bevacizumab arm (2.5%).

Bevacizumab-adcd is Celltrion’s third oncology biosimilar approved for use in the United States, following the approval of rituximab-abbs (Truxima) and trastuzumab-pkrb (Herzuma). The newly approved drug is a recombinant, humanized monoclonal antibody that binds to vascular endothelial growth factor (VEGF), the key driver of vasculogenesis and angiogenesis. 

Bevacizumab-adcd inhibits the binding of VEGF to its receptors Flt-1 (VEGFR-1), and kinase insert domain receptor (KDR) (VEGFR-2), on the surface of endothelial cells. 

More Safety Data

Although bevacizumab-adcd and the reference product are deemed to be similar in terms of safety, both medications carry several warnings and precautions about potentially severe adverse reactions, including gastrointestinal perforation and fistula, severe or fatal hemorrhages and arterial thromboembolic events.

For more details, see the full prescribing information.

https://www.pharmacypracticenews.com/FDA-Approvals/Article/09-22/FDA-Approves-Vegzelma-a-Biosimilar-to-Bevacizumab-for-Six-Types-of-Cancer/68177




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