F.D.A. Staff Warns on Cancer Drug Side-Effects


WASHINGTON, Dec. 3 (Reuters) — Benefits of Roche Holding AG’s Avastin in breast cancer should be weighed against toxic side-effects including the potential for death, United States regulatory staffers said in documents released today.
The Food and Drug Administration staff review comes ahead of a Wednesday advisory panel meeting on a bid by Roche and Genentech to extend use of the drug, already approved to treat lung and colon cancer, to patients with breast cancer.
The panel will advise the F.D.A. on whether to broaden use of the drug to a first-line treatment for breast cancer patients whose disease has spread. About 41,000 women died from breast cancer in 2004, the last year cited by the Centers for Disease Control and Prevention, making it among the top 10 killers of women.
In a key trial, the drug failed to extend overall survival, although it did meet its primary goal of extending “progression-free survival,” the probability that a patient will remain alive, without the disease getting worse.
A median five-and-a-half-month improvement in progression-free survival “must be weighted against the increased toxicity, including deaths associated” with the drug, F.D.A. staff members wrote in an executive summary, posted on agency’s Web site.
The drug already reaps blockbuster sales — $2.65 billion in the first nine months of this year. Shares of Roche are expected to take a significant hit if F.D.A. advisers go against the conventional wisdom, which predicts approval.
“The risk-reward for this short period of time is against Roche,” said Denise Anderson, an analyst at Landsbanki Kepler. “I think everybody does expect the drug will be recommended for approval in the indication, so if it’s not obviously that would be quite a disappointment.”
Avastin is made by Genentech, the biotechology company based in South San Francisco, Calif., which is majority-owned by Roche, the Swiss drugmaker.
In mid-afternoon trading, Genetech’s shares were off nearly 4 percent, to $73.21.
Doctors are already prescribing the drug for breast cancer, a practice known as off-label use, but a broader label indication in the world’s biggest market would help reimbursement. Avastin is already cleared for breast cancer in Europe.