New Indication for Avastin
December 6, 2016 – The U.S. FDA approved Avastin® (bevacizumab), manufactured by Genentech, as treatment for patients with epithelial ovarian, fallopian tube or primary peritoneal cancers that return six months or longer after being treated with a platinum-based therapy. Avastin is a monoclonal antibody that blocks vascular endothelial growth factor (VEGF), a protein that helps tumors grow and spread. Since it was originally approved in 2004, it has been granted several additional indications.
To treat platinum-sensitive cancers, Avastin is given in combination with the other drugs as an intravenous (IV) infusion once every three weeks for at least six cycles. If used with carboplatin and paclitaxel, up to two additional combination cycles may be given; if used with carboplatin and gemcitabine, up to four more combination cycles may be used. After the last combination-therapy cycle, Avastin is then given alone once every three weeks. Dosing is 15mg per Kg of body weight.
A boxed warning cautions that Avastin may cause hemorrhaging, punctures in the gastrointestinal (GI) tract or complications with wound healing. Because it may interfere with healing, using it should be stopped 28 days or longer before planned surgery and not resumed until after the surgical incision is totally healed (at least 28 days after the procedure).
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 regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular 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
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.