FDA Approves Bevacizumab Biosimilar for Six Cancer Types

The FDA has granted approval to bevacizumab-adcd (Vegzelma), a biosimilar to bevacizumab (Avastin), for the treatment of 6 types of cancer, including 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.¹

The basis of this approval of bevacizumab-adcd comes from the totality of evidence, including a pivotal phase 3 trial (NCT03676192) in patients with metastatic or recurrent nonsquamous NSCLC. Findings from the study revealed frontline treatment with bevacizumab-adcd to be highly similar to the reference product in terms of efficacy, safety, and pharmacokinetics.

Following the approval of rituximab-abbs (Truxima) and trastuzumab-pkrb (Herzuma), bevacizumab-adcd is the third oncology biosimilar produced by Celltrion to receive approval in the United States. Further, the European Union approved bevacizumab-adcd in August 2022 and the United Kingdom and Japan earlier in September 2022, with regulatory reviews ongoing in other countries.

“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 Claire Verschraegen, director of the Division of Medical Oncology at the Ohio State University Comprehensive Cancer Center in Columbus, Ohio, 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.”

The pivotal, double-Blind, randomized, active-controlled, parallel-group, phase 3 trial aimed to compare the efficacy and safety of bevacizumab-adcd in the frontline for patients with metastatic or recurrent nonsquamous NSCLC.²

A total of 689 patients aged 18 years and older with recurrent or stage IV nonsquamous NSCLC who had at least 1 measurable lesion by RECIST v1.1 criteria were enrolled in the trial.2 Those with predominantly squamous cell histology or who had surgery for metastatic nonsquamous NSCLC were excluded from the trial.

In the experimental arm, 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 therapy. Within the comparator arm, patients were given the same dose and schedule of bevacizumab. In both arms, treatment was continued until progressive disease or intolerable toxicity.

The primary end point of the trial was objective response rate.

Findings showed that regarding safety, the most frequent adverse events which occurred in more than 10% of patients were epistaxis, headache, hypertension, rhinitis, proteinuria, taste alteration, dry skin, hemorrhage, lacrimation disorder, back pain, and exfoliative dermatitis.

“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,” said Jaeik Shim, chief operating officer at Celltrion USA, 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 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 30, 2022. https://yhoo.it/3E3VPOr

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 30, 2022. https://clinicaltrials.gov/ct2/show/NCT03676192