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

December 3, 2007

December 3, 2007

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

By THE ASSOCIATED PRESS

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

, 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.

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.

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