First Cancer Biosimilar Drug Gets FDA Approval

The FDA today approved bevacizumab-awwb (Mvasi) as a biosimilar to the cancer drug bevacizumab (Avastin).

Mvasi is the first biosimilar approved in the United States to treat cancer, according to a press release. It is indicated to treat adult patients with certain types of colorectal, lung, brain, kidney, and cervical cancers.

The approval is based on evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data, and other clinical safety and efficacy data demonstrating Mvasi is highly similar to the reference product Avastin.

“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,” said FDA Commissioner Scott Gottlieb, MD, in the 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.”

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The most common adverse events (AEs) of Mvasi included epistaxis, headache, hypertension, rhinitis, proteinuria, taste alteration, dry skin, hemorrhage, lacrimation disorder, back pain, and exfoliative dermatitis.

Serious AEs include perforation or fistula, arterial and venous thromboembolic events, hypertension, posterior reversible encephalopathy syndrome, proteinuria, infusion-related reactions and ovarian failure.

The following are specific approved indications for Mvasi:

• Metastatic colorectal cancer, in combination with intravenous 5-fluorouracil-based chemotherapy for first- or second-line treatment.
• Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrmidine-oxaliplatin-based chemotherapy for the second-line treatment of patients who progressed on a first-line bevacizumab-based regimen.
• 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.
• 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.