FDA approves first biosimilar treatment for cancer

Mvasi, a biosimilar to the cancer drug Avastin, is approved for certain colorectal, lung, brain, kidney and cervical cancers.
By Amy Wallace  |  Sept. 14, 2017 at 1:30 PM
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Sept. 14 (UPI) -- The U.S. Food and Administration today announced its approval the first biosimilar for the treatment of certain types of cancer.

The FDA approved Mvasi, or bevacizumab-awwb, as a biosimilar to Avastin, or bevacizumab, in the United States for the treatment of certain colorectal, lung, brain, kidney and cervical cancers in adults.

A biosimilar is a biological product that is highly similar to an already-approved biological product, and has no clinically meaningful differences related to safety, purity or potency from the original 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 Dr. Scott Gottlieb, 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."

Mvasi is approved for the treatment of metastatic colorectal cancer in combination with intravenous 5-fluorouracil-based chemotherapy, 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 product.

It is also approved for the treatment of Non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel for first line treatment, glioblastoma with progressive disease following prior therapy based on improvement in objective response rate, metastatic renal cell carcinoma, and cervical cancer that is persistent, recurrent or metastatic in combination with paclitaxel and cisplatin or paclitaxel and topotecan.

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