SPECIALTY RX FACTS

1Sep/110

FDA links infections to repackaged Avastin

FDA said at least 12 patients developed serious eye infections, including some leading to vision loss, following intravitreal injections of repackaged Avastin bevacizumab to treat wet age-related macular degeneration at three Florida clinics. The agency traced the bacterial infections to a single pharmacy in Hollywood, Florida, which repackaged the IV cancer drug into single-use syringes for off-label treatment of wet AMD. FDA recalled all Avastin
repackaged at the pharmacy.

The humanized mAb against VEGF from Genentech Inc. is approved for multiple cancers and is used off-label in wet AMD as a cheaper alternative to Genentech's Lucentis ranibizumab, a mAb fragment against VEGF-A. In April, NIH's National Eye Institute reported that Avastin was non-inferior
to Lucentis in the Phase III CATT trial for wet AMD (see BioCentury May 2).

Genentech said in a statement that it does not support or promote the off-label use of Avastin. The company added that other ocular adverse events have been reported from unapproved use of Avastin for eye disorders.

In April 2010, FDA received reports of five eye infections in Tennessee linked to Avastin repackaged at a single compounding pharmacy. Genentech, a unit of Roche (SIX:ROG; OTCQX:RHHBY), markets Avastin and Lucentis in the U.S., while the drugs are marketed elsewhere by Roche and Novartis, respectively.

Comments (0) Trackbacks (0)

No comments yet.


Leave a comment

No trackbacks yet.