FDA Approves Bevacizumab-adcd Biosimilar in Six Solid Tumors

FDA

The FDA has approved bevacizumab-adcd (Vegzelma), a bevacizumab (Avastin) biosimilar, for the treatment of six types of cancer: 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 approval of bevacizumab-adcd is based on the totality of evidence, which includes the pivotal phase 3 trial (NCT03676192) in patients with metastatic or recurrent nonsquamous NSCLC. Results from the study showed that frontline treatment with bevacizumab-adcd is highly similar to the reference product in terms of 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 in Columbus, Ohio, 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.”

Bevacizumab-adcd is Celltrion’s third oncology biosimilar that has received approval for use in the US, following the approval of rituximab-abbs (Truxima) and trastuzumab-pkrb (Herzuma). Previously, bevacizumab-adcd was approved in the European Union in August 2022 and the United Kingdom and Japan earlier in September 2022. Regulatory reviews are underway in other countries.

The pivotal phase 3 trial enrolled patients at least 18 years of age with recurrent or stage IV nonsquamous NSCLC who had at least 1 measurable lesion by RECIST v1.1 criteria.²

Patients were excluded from enrollment if they had predominantly squamous cell histology or had surgery for metastatic nonsquamous NSCLC.

In the experimental arm, patients received 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. In the comparator arm, patients received the same dose and schedule of bevacizumab. Treatment was continued until progressive disease or intolerable toxicity.

The primary end point was the objective response rate.

Regarding safety, the most frequent adverse effects occurring in more than 10% of patients are 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 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. https://clinicaltrials.gov/ct2/show/NCT03676192