Avastin: One of the World's Top-Selling Breast Cancer Drugs
Editor's Note: The U.S. Food and Drug Administration on 2/22/08 approved the cancer drug Avastin for women with advanced breast cancer, going against the recommendation of its own advisory panel. Also see PJ's postscript at the end of this post for more details.
Avastin, a drug that’s shown great promise in slowing the progress of metastatic breast cancer, has been in the news again lately. No, not in the Journal of the American Medical Association. Nor even in American Cancer Society’s CA, the most widely circulated oncology journal in the world. Nope, when I searched Google News for Avastin the other night, one entry came up: an article in TheStreet.com, a Wall Street financial company and Web site offering readers market news and investment advice.
And the connection is…? Money. Stock prices. Avastin, with its cutting-edge ability to starve cancerous tumors by throttling their blood supply, is expected to be one of the world’s top-selling drugs. Like the high school baseball pitcher who’s been a standout since Little League and is finally on the verge of being drafted by Major League Baseball, Avastin is a rising star that’s right on the edge of becoming a supernova. It helps cancer patients.
And more important, for investors in its manufacturer, Genentech, and Genentech’s parent company, Roche Holding AG, it makes money. LOTS of money. Even without approval as a breast cancer drug (it’s presently approved for treatment of colon and some long cancers), Avastin’s sales in the United States topped $2.3 billion last year. And up to $250 million of those sales came through its use as an “off label” (not approved) breast cancer drug. Those sales would skyrocket an estimated $1 billion to $2 billion should Avastin gain FDA approval for breast cancer treatment.
Thus, when the news came Dec. 5 that an FDA expert panel had voted 5-4 to reject Avastin (bevacizumab) as an approved breast cancer treatment because of serious side effects, Roche’s stock fell more than 5% — a huge tumble, when you’re talking about a company whose 2007 sales totaled a whopping $46.1 billion. And last week, when Genentech reported that a new clinical trial (the AVADO trial) replicated the results of an earlier trial that showed Avastin was effective in prolonging progression-free disease (i.e., women’s tumors stopped growing), Genentech’s stock rose 2.4%.
Interesting, the timing of this new study. With the FDA expected to approve or reject Avastin for use against breast cancer tomorrow (Saturday, Feb. 23) — and with the FDA’s expert panel already having recommended rejection — it’s critical that Genentech does everything possible to protect and promote its golden-egg-laying goose.
In a press release published last week, Genentech spokesmen wrote, "We have shared the AVADO data with the FDA to assist the agency in assessing the risk and benefit of Avastin in this patient population. Genentech believes that the results of the AVADO study provide confirmation of Avastin's efficacy and safety in this patient population."
In a surprise turn of events, biotech blogs have been reporting that two members of the FDA’s expert panel, who’d previously advised against approval, now say they want to change their vote—which would tip the balance in Genentech’s favor.
Bottom line, exactly how effective is Avastin for women with metastatic breast cancer? The initial study results, the data that guided the FDA’s expert panel, showed a slowing of breast cancer’s progression; but there’s not yet enough data to know whether Avastin also lengthens survival time. In addition, Avastin’s potential side effects are quite serious: six (of 363) women in the trial died due to Avastin-precipitated heart damage. If, as reported, the AVADO trial shows similar results to the initial trial, then those side effects haven’t gone away; and the survival time issue still hasn’t been resolved. While the AVADO trial does indeed reinforce the results of the initial trial, is that enough to steer the FDA away from its expert panel’s recommendation to reject the drug?
Genentech and Roche investors certainly hope so. As breast cancer survivors, and potential future customers for Avastin, our hope might be that the FDA approves Avastin. And we must trust that the FDA’s approval would be based on the drug’s effectiveness–not on how its decision would go down on Wall Street.
Postscript: The FDA announced late Friday that it has approved Avastin for breast cancer treatment. "The FDA has lowered the bar under pressure from the industry,” said Barbara Brenner, executive director of Breast Cancer Action in San Francisco, quoted in The San Francisco Chronicle. Dr. Lisa Bailey, a breast cancer surgeon and past president of the California division of the American Cancer Society–also interviewed in the Chronicle—said, "I'm glad they're (FDA officials) considering other things besides survival. I think that's very important, because quality-of-life issues need to be included. This potentially gives women more options."
In after-hours trading, Genentech stock rose $5.80 (8 percent) on news of the approval.