FDA Approves Genentech’s Colon Cancer Drug Avastin
FDA Thursday approved Genentech's Avastin as an initial treatment with standard chemotherapy for metastasized colorectal cancer, the Wall Street Journal reports (Hamilton, Wall Street Journal, 2/27). In an "unusual step that reflected the importance cancer doctors have attached to the drug," FDA Commissioner Mark McClellan personally announced the approval, the Washington Post reports. McClellan called Avastin "a significant new improvemen[t] in the armamentarium for fighting colon cancer" (Gillis, Washington Post, 2/27). Avastin, the first drug of its kind to be approved by FDA, works by restricting blood vessels that supply cancerous tumors with oxygen and nutrients, a process known as angiogenesis inhibition, the New York Times reports (Pollack, New York Times, 2/27). In combination with chemotherapy in clinical trials, the drug extended the lives of clinical trial patients by 4.7 months, or 30%, compared with patients on standard chemotherapy alone, the Journal reports (Wall Street Journal, 2/27). That is the largest "survival advantage" for any drug targeting advanced colorectal cancer, Dr. Leonard Saltz, colorectal cancer specialist at Memorial Sloan-Kettering Cancer Center in New York, said (Szabo/Appleby, USA Today, 2/27). In addition, treatment including Avastin is "far less toxic and easier to use in combination than traditional chemotherapy," which can debilitate patients with severe diarrhea, nausea or opportunistic infections, the Journal reports (Wall Street Journal, 2/27). The Times reports that Avastin's label includes a warning about "serious but uncommon side effects" of the drug, including the formation of holes in the colon that can require surgery and lead to infections, impaired wound healing and bleeding from the lungs or internally (New York Times, 2/27). More common side effects include blood clots, diarrhea, fatigue, appetite loss and increased risk of infection because of white blood cell loss (Elias, AP/San Jose Mercury News, 2/27). Sue Hellman, chief medical officer at Genentech, said that hypertension, Avastin's leading side effect, can be treated with high blood pressure medications (USA Today, 2/27).
Genentech officials said that the company began shipping Avastin Thursday afternoon and that patients should be able to begin treatment next week, the San Francisco Chronicle reports (Colliver/Tansey, San Francisco Chronicle, 2/27). Genentech officials also said that they do not anticipate problems keeping up with demand, and they expect private insurers and Medicare will cover the drug (Wall Street Journal, 2/27). Avastin will cost about $4,400 per month, and data from the clinical trials suggest that patients will use the drug for an average of about 10 months, the Times reports. The cost of Avastin "will be certainly reflected in the cost of health care at the end of the year," Dr. Heinz-Josef Lenz, a colon cancer expert at the University of Southern California, said (New York Times, 2/27). Analysts predict the drug will reach annual sales of $2 billion or more, the Journal reports (Wall Street Journal, 2/27). Sales could rise above $2 billion because of FDA's "broader than expected wording" of Avastin's label, which allows the drug to be used "more liberally than expected," the Times reports (New York Times, 2/27). Many doctors and analysts believe Avastin will be effective at treating other cancers as well, the Journal reports (Wall Street Journal, 2/27). Colorectal cancer afflicts about 150,000 U.S. residents per year and causes about 57,000 deaths, the Boston Globe reports (Dembner, Boston Globe, 2/27). An estimated 69,000 U.S. residents have colon or rectal cancer that has spread to other parts of the body, which Avastin is approved to treat (Jacobs, San Jose Mercury News, 2/27). Currently, Avastin is in late-stage clinical tests for cancer of the breast, kidney and lung and is being tested with other combinations of chemotherapy for colon cancer (Boston Globe, 2/27).
Kevin Lewis, board chair of the Colon Cancer Alliance, said, "To arrest the disease for a while or extend life gives patients the chance to get into other clinical trials. It's about hope for patients, and this certainly gives patients a lot more hope" (San Francisco Chronicle, 2/27). Judah Folkman, a researcher at Children's Hospital in Boston and pioneer in the study of angiogenesis inhibition, said, "Avastin has been a real turning point in cancer, and a milestone in anti-angiogenesis" (Wall Street Journal, 2/27). Louise Grochow, chief of investigational drugs at the National Cancer Institute, said that with the approval of Avastin and other drugs like it, "you're talking about turning these diseases that people think of as death sentences into chronic illnesses" (Washington Post, 2/27). However, Len Lichtenfeld, deputy chief medical officer at the American Cancer Society, said drugs like Avastin "are a small step forward," adding, "We're at the end of the beginning rather than the beginning of the end" (Wall Street Journal, 2/27).
The following programs reported on FDA approval of Avastin:
- NBC's "Nightly News" on Thursday reported on Avastin. The segment includes comments by Saltz and Herbert Hurwitz, Assistant Professor of Medicine at Duke University Medical Center (Bazell, "Nightly News," NBC, 2/26). The complete segment in available online in Windows Media.
- NPR's "Morning Edition" on Friday reported on the FDA approval of Avistan and of Erbitux earlier this month. The segment includes comments by Folkman and David Cheresh of the Scripps Research Institute (Knox, "Morning Edition, 2/27). The complete segment is available online in RealPlayer.