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10/14/03

Genentech completes cancer drug filing to FDA

NEW YORK (Reuters) - Genentech Inc., the world’s second largest biotechnology company, on Monday said it completed an application for U.S. approval to sell its experimental drug Avastin to treat colon cancer.

Genentech’s stock soared in June when it reported positive results from a late-stage clinical trial of the drug. The treatment is potentially the first of a new class of anti-angiogenesis therapies designed to stop the blood supply to tumors.

In June, the U.S. Food and Drug Administration gave the drug fast-track status, meaning authorities would review data as it became available rather than wait for a complete application.

Genentech said it is now seeking so-called "priority review" status, under which the FDA would commit to a decision on the drug within six months.

Results from an 800-patient trial of Avastin showed that previously untreated patients given a combination of the biotech drug and chemotherapy known as the Saltz regimen lived an average of 20.3 months compared with 15.6 months for patients on chemotherapy alone.

Genentech said it expects to report results from another pivotal trial of the drug, this time in combination with a different type of chemotherapy, in the fourth quarter of this year.

The company is also studying Avastin as a treatment for other types of cancer.

Unlike chemotherapy, which kills cancer cells along with other fast-dividing yet healthy cells such as hair follicles and bone marrow, Avastin is an antibody designed to target only cells involved in the cancer.

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