First Biosimilar Treatment For Cancer Approved By The FDA

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On Thursday, the U.S. Food and Drug Administration approved Myasi as a biosimilar to Avastin for the treatment of a variety of cancers. Myasi will be the first biosimilar approved in the United States for the treatment of cancer.

“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,” stated FDA Commissioner Scott Gottlieb, M.D. “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 adult patients with specific colorectal, lung, brain, kidney and cervical cancers. Particularly, 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 unrespectable, locally advanced, recurrent or metastatic disease.

Biological products usually come from a living organism and can root from numerous sources, such as humans, animals, microorganisms or yeast. A biosimilar is a biological product that is approved based on data displaying that it is very similar to an already-approved biological product and has no clinically strong differences in terms of safety, purity and potency from the reference product, furthermore to meeting other criteria defined by law.

The reason behind FDA’s approval of Myasi is evidence that entailed in depth structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data and a variety of other data that show Myasi is biosimilar to Avastin. It’s important to note that is has been approved as a biosimilar, not as an interchangeable treatment.

The common side effects of Myasi are things such as, headaches, high blood pressure, nosebleeds, back pain, rectal bleeding, inflammation of the nasal cavity, and more.

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