Avastin Receives New Indication
June 13, 2018 – The U.S. FDA has approved a new indication for Avastin® (bevacizumab), manufactured by Genentech. The drug is now approved for use in combination with chemotherapy (carboplatin and paclitaxel), and then as a single agent following chemotherapy, to treat women who have advanced (stage III or IV) ovarian cancer and who have undergone initial surgical resection.
Approximately 80% of ovarian cancer is identified only after it has reached an advanced stage. A monoclonal antibody, Avastin helps to inhibit tumor growth by blocking a specific protein. Median progression free survival with Avastin in a clinical study of women with ovarian cancer was 18.2 months. With chemotherapy alone, the median progression free survival time was 12 months.
Avastin carries a black box warning cautioning that its use is associated with gastrointestinal perforation, surgery and wound healing complications, and severe or fatal hemorrhage. The product holds ten U.S. FDA approved indications across six different types of cancer, and was first approved for use in the United States in 2004.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.