FDA Grants Approval to Bevacizumab-awwb as First Biosimilar for Anticancer Therapy

Share this content:
FDA examination found significant no efficacy or safety differences between bevacizumab-awwb and its reference product .
FDA examination found significant no efficacy or safety differences between bevacizumab-awwb and its reference product .

The US Food and Drug Administration (FDA) granted approval to bevacizumab-awwb for the treatment of adult patients with certain brain, cervical, colorectal, kidney, and lung cancers.

Bevacizumab-awwb is a recombinant IgG1 monoclonal antibody that binds to vascular endothelial growth factor (VEGF) and inhibits angiogenesis. It is the first biosimilar approved in the US for anticancer therapy.

The FDA based its approval on evidence demonstrating that bevacizumab-awwb has no clinically significant differences from its reference product in terms of structural and functional characterization, data collected from animal studies, pharmacokinetic and pharmacodynamics profiles in humans, immunogenicity, and safety and efficacy data.

Commonly reported adverse events for bevacizumab-awwb include epistaxis, headache, hypertension, rhinitis, proteinuria, taste alterations, rectal hemorrhage, dry skin, lacrimation disorder, back pain, and exfoliative dermatitis.

Bevacizumab-awwb has a boxed warning alerting prescribers and patients to the risk of gastrointestinal perforations, surgery and wound healing complications, and severe or fatal pulmonary, gastrointestinal, central nervous system, and vaginal bleeding.

Reference

1. FDA approves first biosimilar for the treatment of cancer [news release]. Silver Spring, MD: US food and Drug Administration. Updated September 14, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm576112.htm. Accessed September 14, 2017.

You must be a registered member of ONA to post a comment.

Sign Up for Free e-newsletters

Regimen and Drug Listings

GET FULL LISTINGS OF TREATMENT Regimens and Drug INFORMATION

Bone Cancer Regimens Drugs
Brain Cancer Regimens Drugs
Breast Cancer Regimens Drugs
Endocrine Cancer Regimens Drugs
Gastrointestinal Cancer Regimens Drugs
Genitourinary Cancer Regimens Drugs
Gynecologic Cancer Regimens Drugs
Head and Neck Cancer Regimens Drugs
Hematologic Cancer Regimens Drugs
Lung Cancer Regimens Drugs
Other Cancers Regimens
Rare Cancers Regimens
Skin Cancer Regimens Drugs