First Anticancer Biosimilar Treatment Approved for Multiple Indications

The FDA has approved bevacizumab-awwb (Mvasi) as treatment for multiple cancers. The drug has been approved as a biosimilar to its reference biologic, bevacizumab (Avastin), but it has not been approved as an interchangeable product.

Mvasi, developed via a partnership between Amgen and Allergan, is approved for the treatment of adult patients suffering from either colorectal cancer, glioblastoma, cervical cancer, or non-squamous non—small cell lung cancer. Specifically, the approved indications include:

• Metastatic colorectal cancer, in combination with intravenous 5-fluorouracil-based chemotherapy for first- or second-line treatment. Mvasi is not indicated for the adjuvant treatment of surgically resected colorectal cancer.
• Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrmidine-oxaliplatin-based chemotherapy for the second-line treatment of patients who have progressed on a first-line bevacizumab product-containing regimen. Mvasi is not indicated for the adjuvant treatment of surgically resected colorectal cancer.
• Non-squamous non—small cell lung cancer, in combination with carboplatin and paclitaxel for first line treatment of unresectable, locally advanced, recurrent or metastatic disease.
• Glioblastoma with progressive disease following prior therapy, based on improvement in objective response rate. No data is available demonstrating improvement in disease-related symptoms or survival with bevacizumab products.
• Metastatic renal cell carcinoma, in combination with interferon alfa.
• Cervical cancer that is persistent, recurrent, or metastatic, in combination with paclitaxel and cisplatin or paclitaxel and topotecan.

FDA Commissioner Scott Gottlieb, MD, said in a statement, “Bringing new biosimilars to patients, especially for diseases where the cost of existing treatments can be high, is an important way to help spur competition that can lower healthcare costs and increase access to important therapies." He added that the FDA will continue on its track to bring new biosimilar medications to the market quickly “through a process that makes certain that these new medicines meet the FDA’s rigorous gold standard for safety and effectiveness.”

The approval follows 2 months after a unanimous (17-0) vote by the FDA’s Oncologic Drugs Advisory Committee to approve the drug.

The evidence submitted for FDA review included structural and functional characterization of bevacizumab-awwb, along with animal study data, pharmacokinetic and pharmacodynamic study data in humans, clinical immunogenicity data, and other safety and efficacy data.

The reference bevacizumab is manufactured by Genentech and was approved in February 2004.

AJMC

In the following video, Bruce A. Feinberg, DO, discusses the adoption of biosimilars among community oncologists with 's Center for Biosimilars.