FDA approves first-ever biosimilar for cancer treatment
pharmafile | September 15, 2017 | News story | Medical Communications, Sales and Marketing | Amgen, Cancer, FDA, Mvasi, avastin, biosimilar
The FDA has announced the news that it has awarded approval to the first-ever biosimilar for the treatment of cancer in the US – Amgen’s Mvasi (bevacizumab-awwb), a biologic version of Genetech’s Avastin (bevacizumab).
The drug is approved as a therapy for colon, lung, brain, kidney and cervical cancers. These include:
- Metastatic colorectal cancer, in combination with intravenous 5-fluorouracil-based chemotherapy for first- or second-line treatment, or 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.
- 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.
Like its reference product, Mvasi carries a boxed warning advising on a number of increased risks posed by the drug, including holes in the stomach and intestines (gastrointestinal perforations), wound healing complications, and severe or fatal pulmonary, gastrointestinal, central nervous system and vaginal bleeding. Because of these risks, the FDA advises that patients do not use the drug within 28 days of an elective surgery ad to stop using immediately if gastrointestinal perforations occur.
“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,” commented FDA Commissioner Scott Gottlieb. “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.”
Matt Fellows
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