FDA Approves First Biosimilar for Cancer Treatment

The US Food and Drug Administration (FDA) has approved Mvasi (bevacizumab-awwb, Amgen) as a biosimilar to Avastin (bevacizumab, Genentech) for the treatment of multiple types of cancer including colorectal, lung, brain, kidney, and cervical cancers. This approval is the first biosimilar approved for the treatment of cancer in the United States.

The approval was based on a review of data that included extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data, and other clinical safety and effectiveness data that demonstrates Mvasi is biosimilar to Avastin.

The FDA noted that Mvasi has been approved as a biosimilar to Avastin but not as an interchangeable product.

“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,” FDA Commissioner Scott Gottlieb, MD, said in a press release. “We’ll continue to work hard to ensure that biosimilar medications are brought 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 specific indications outlined by the FDA include:

Metastatic Colorectal Cancer

• In combination with intravenous 5-fluorouracil–based chemotherapy for first- or second-line treatment. Not indicated for the adjuvant treatment of surgically resected colorectal cancer.

• In combination with fluoropyrimidine/irinotecan- or fluoropyrimidine/oxaliplatin-based chemotherapy for the second-line treatment of patients who have progressed on a first-line bevacizumab product–containing regimen. Not indicated for adjuvant treatment of surgically resected cancer.

Nonsquamous Non–Small-Cell Lung Cancer

• In combination with carboplatin and paclitaxel for the 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

• For persistent, recurrent, or metastatic disease, in combination with paclitaxel and cisplatin or paclitaxel and topotecan.

The label for Mvasi contains a boxed warning to alert healthcare professionals and patients about increased risk for gastrointestinal perforation, surgery and wound healing complications, severe or fatal pulmonary, gastrointestinal, and central nervous system and vaginal hemorrhage.