FDA Approves First Biosimilar for the Treatment of Cancer

Key Points

  • Bevacizumab-awwb is approved for the treatment of adult patients with certain colorectal, lung, brain, kidney and cervical cancers.
  • A biosimilar is a biologic product that is approved based on data showing that it is highly similar to an already-approved biologic product and has no clinically meaningful differences in terms of safety and efficacy from the reference product.

The U.S. Food and Drug Administration today approved bevacizumab-awwb (Mvasi) as a biosimilar to bevacizumab (Avastin) for the treatment of multiple types of cancer. Bevacizumab-awwb is the first biosimilar approved in the U.S. 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 health-care costs and increase access to important therapies,” said FDA Commissioner Scott Gottlieb, MD. “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.”

Approved Indications

Bevacizumab-awwb is approved for the treatment of adult patients with certain colorectal, lung, brain, kidney, and cervical cancers. Specifically, the approved indications include:

  • Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment. Bevacizumab-awwb 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. Bevacizumab-awwb is not indicated for the adjuvant treatment of surgically resected colorectal cancer.
  • Nonsquamous 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 are 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.

Health-care professionals should review the prescribing information in the labeling for detailed information about the approved uses.

Biologic products are generally derived from a living organism and can come from many sources, such as humans, animals, microorganisms or yeast. A biosimilar is a biologic product that is approved based on data showing that it is highly similar to an already-approved biologic product and has no clinically meaningful differences in terms of safety, purity, and potency (ie, safety and effectiveness) from the reference product, in addition to meeting other criteria specified by law.

The FDA's approval of bevacizumab-awwb is based on review of evidence 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 bevacizumab-awwb is biosimilar to bevacizumab. It has been approved as a biosimilar, not as an interchangeable product.

Safety Profile

Common expected side effects of bevacizumab-awwb include nose bleeds, headache, hypertension, rhinitis, proteinuria, taste alteration, dry skin, rectal hemorrhage, excessive tear production, back pain, and skin irritation.

Serious expected side effects of bevacizumab-awwb include organ perforation or fistula, arterial and venous thromboembolic events, hypertension, posterior reversible encephalopathy syndrome, proteinuria, infusion-related reactions, and ovarian failure. Patients should stop using bevacizumab-awwb if these side effects become severe or life-threatening. Women who are pregnant should not take bevacizumab-awwb because it may cause harm to a developing fetus.

Like bevacizumab, the labeling for bevacizumab-awwb contains a Boxed Warning to alert health-care professionals and patients about an increased risk of gastrointestinal perforations; surgery and wound healing complications; and severe or fatal pulmonary, gastrointestinal, central nervous system, and vaginal hemorrhage. Patients should stop using bevacizumab-awwb if gastrointestinal perforation occurs. Patients should not take bevacizumab-awwb in the 28 days prior to and after elective surgery and until the surgical wound is fully healed. Patients should stop using bevacizumab-awwb if a surgical incision breaks open. Bevacizumab-awwb should not be given to patients with severe hemorrhage or in patients who cough up blood.

The FDA granted approval of bevacizumab-awwb to Amgen, Inc. Bevacizumab was approved in February 2004, and is manufactured by Genentech, Inc.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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