FDA Approves Bevacizumab-adcd Biosimilar in 6 Cancer Types

Based on results from a phase 3 trial, a bevacizumab biosimilar, bevacizumab-adcd, was approved by the FDA for patients with metastatic or recurrent non-squamous non–small cell lung in addition to 5 other disease types.

Bevacizumab biosimilar bevacizumab-adcd (Vegzelma) has been approved by the FDA as a treatment in 6 types of cancers including metastatic colorectal cancer; recurrent or metastatic non-squamous non–small cell lung cancer (NSCLC); recurrent glioblastoma; metastatic renal cell carcinoma (RCC); persistent, recurrent, or metastatic cervical cancer; and epithelial ovarian, fallopian tube, or primary peritoneal cancer, according to a press release from Celltrion.1

The regulatory decision was based on totality of evidence, including a phase 3 trial (NCT03676192) assessing the bevacizumab biosimilar vs bevacizumab (Avastin) in patients with metastatic or recurrent non-squamous NSCLC. Notably, data on bevacizumab-adcd use in the first line showed similar results in terms of efficacy, safety profile, and pharmacokinetics compared with bevacizumab.2

Bevacizumab-adcd is an anti-cancer monoclonal antibody treatment biosimilar of bevacizumab. It binds to VEGF and inhibits the binding to the receptors on Flt-1 (VEGFR-1) and kinase insert domain receptor (VEGFR-2) on the surface of the endothelial cells.

“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,” Claire Verschraegen, director of the Division of Medical Oncology at the Ohio State University Comprehensive Cancer Center in Columbus, Ohio, said in the press release. “With the availability of biosimilars such as [bevacizumab-adcd] in the United States, oncologists will have additional treatment options for patients across multiple cancer types.”

In the aforementioned, double-blind, randomized trial, a total of 689 patients were enrolled. Patients were treated with 15 mg/kg of bevacizumab-adcd intravenously every 3 weeks for up to 6 cycles during the induction study period and every 3 weeks thereafter until progressive disease occurred during the maintenance period. Patients received matched treatment in the bevacizumab arm.

The primary end point of the study was objective response rate at 21 weeks.

Patients were included in the trial if they were diagnosed with recurrent or stage IV disease and had at least 1 measurable lesion by RECIST v 1.1 criteria. Patients were excluded if they had predominant squamous cell histology NSCLC or had prior surgery for metastatic non-squamous NSCLC.

In August 2022, bevacizumab-adcd was approved by the European Commission for patients with metastatic breast cancer, NSCLC, advanced and/or metastatic RCC, metastatic carcinoma of the colon or rectum, ovarian cancer, and cervical cancer.3

“The approval of [bevacizumab-adcd] is an important milestone in the United States which adds to our growing portfolio of oncology treatments and marks an important step forward in expanding access to cancer care,” Jaeik Shim, chief operating officer at Celltrion USA, said in the press release. “As a leading force in the global biopharmaceutical industry, we look forward to working with payers and providers to make our product available to patients. With our high-quality and affordable biosimilar medicines, we plan to strengthen our presence in the United States and contribute to a more sustainable healthcare system for the future.”

References

  1. Celltrion USA receives U.S. FDA approval for its oncology biosimilar Vegzelma® (bevacizumab-adcd) for the treatment of six types of cancer. News Release. Celltrion. September 28, 2022. Accessed September 28, 2022. https://yhoo.it/3LP89Up
  2. FDA approves atezolizumab with chemotherapy and bevacizumab for first-line treatment of metastatic non-squamous NSCLC. News Release. FDA. December 6, 2018. Accessed September 28, 2022. https://bit.ly/31GqGdf
  3. European Commission approves Celltrion Healthcare’s Vegzelma™ (CT-P16, biosimilar bevacizumab) for the treatment of multiple types of cancer. News Release. Incheon. August 18, 2022. Accessed September 28, 2022. https://bwnews.pr/3UJDBaJ