FDA Approves Bevacizumab Biosimilar for Six Types of Cancer

The FDA has approved bevacizumab-adcd (Vegzelma) for the treatment of 6 types of cancer. The biosimilar to bevacizumab (Avastin) was approved for recurrent or metastatic nonsquamous non–small cell lung cancer (NSCLC); recurrent glioblastoma; metastatic colorectal cancer; persistent, recurrent, or metastatic cervical cancer; metastatic renal cell carcinoma; and epithelial ovarian, fallopian tube, or primary peritoneal cancer.¹

The approval was based on data that include a pivotal phase 3 trial (NCT03676192) in patients with metastatic or recurrent nonsquamous NSCLC. The study found that frontline treatment with bevacizumab-adcd is highly similar to reference bevacizumab in efficacy, safety, and pharmacokinetics.

“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, said in a 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.”

The trial on which the approval was based enrolled patients at least 18 years of age with recurrent or stage IV nonsquamous NSCLC with at least 1 measurable lesion by RECIST v1.1 criteria.²

The investigators excluded patients from enrollment if they had predominantly squamous cell histology or underwent surgery for metastatic nonsquamous NSCLC.

In the experimental biosimilar cohort, patients were administered 15 mg/kg of intravenous bevacizumab-adcd as induction therapy every 3 weeks for up to 6 cycles and every 3 weeks as maintenance treatment. In the control group, patients were administered the same dose and schedule of reference bevacizumab. Treatment continued until disease progression or intolerable toxicity, with a primary end point of objective response rate.

The most frequent adverse effects occurring in more than 10% of patients during treatment with bevacizumab were epistaxis, headache, hypertension, rhinitis, proteinuria, taste alteration, dry skin, hemorrhage, lacrimation disorder, back pain, and exfoliative dermatitis.

Bevacizumab-adcd is the third oncology biosimilar produced by Celltrion gain FDA approval in the United States, with rituximab-abbs (Truxima) and trastuzumab-pkrb (Herzuma) both approved in 2018. Bevacizumab-adcd has also been approved in the European Union, the United Kingdom, and Japan in 2022, with regulatory reviews ongoing in other countries.

“The approval of [bevacizumab-adcd] is an important milestone in the US 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 a 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 health-care 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 USA. September 28, 2022. Accessed September 28, 2022. https://bwnews.pr/3BQP6om

2. To compare efficacy and safety of CT-P16 and EU-approved Avastin as first-line treatment for metastatic or recurrent non-squamous non-small cell lung cancer. ClinicalTrials.gov. Updated August 26, 2022. Accessed September 28, 2022.