Avastin

In early December 2003, Genentech announced that the Biologics License Application (BLA) for Avastin (bevacizumab) as a first line therapy in metastatic colorectal cancer had been submitted to the FDA. Genentech requested and received a ‘Priority Review’ designation. Priority Review status means that the FDA will take action on the BLA within six months of receipt of the document, which in Avastin’s case is by the end of March, 2004. Avastin inhibits the function of a protein called Vascular Endothelial Growth Factor (VEGF). Simply put, tumor cells require blood to survive, just like any normal cell in the body. VEGF plays a vital role in the ability of tumor cells to grow new blood vessels, a process called angiogenesis. In theory, inhibiting VEGF with Avastin should interfere with a tumor’s blood supply and prevent growth or spread.

The American Cancer Society estimates that 147 500 new cases of colorectal cancer will be diagnosed in the United States in 2003. This makes colorectal cancer the third most commonly diagnosed cancer and the second leading cause of cancer death in the United States.

According to Genentech, more than 2,000 patients have been treated with Avastin in clinical studies. The current BLA filing is based upon the results of a pivotal 900 patient study of Avastin plus the three other chemotherapy agents comprising the IFL regimen (5-FU/Leucovorin/CPT-11). Genentech reported that Avastin plus the IFL regimen improved median survival by approximately five months, compared to patients treated with chemotherapy alone (20.3 months versus 15.6 months).

Wall Street analysts position Avastin in the 1billion dollar/year sales range. The actual cost per patient treated is not known at this time but new cancer therapies typically cost somewhere in the $12 000 – $20 000 per patient per year range. It is critical to note that these costs will be in addition to the costs of treating metastatic colon cancer with existing chemotherapy regimens as, initially, Avastin will likely be used in addition to the IFL chemotherapy regimen.

If approved, we feel that Genentech’s Avastin has the potential to be a High Impact technology and therefore we recommend oncology programs begin some early assessment activities while watching for the FDA’s decision. Early steps would include the identification of current and predicted metastatic colon cancer patient numbers and some discussion with treating oncologists concerning future plans for Avastin in treatment regimens.

Technology Details
Target Disease / Indication: First Line Therapy in Metastatic Colorectal Cancer
Technology Classification: Drug
Body System: Gastrointestinal System
Program Area: Medicine/Oncology
Regulatory Status: Biologics License Application Submitted to FDA
BioHorizon Impact Score: 70/100 – High