By Randall Osborne

Bolstered by what the company said is an abundance of Phase III data, Genentech Inc. submitted its biologics license application to the FDA for Herceptin (trastuzumab), the first monoclonal antibody against breast cancer.

The drug has been designated a Fast Track Product by the agency, which means it is given priority review.

"Once the clock starts, the FDA has six months to render a decision," said Marie Kennedy, spokeswoman for South San Francisco-based Genentech. "They have an enormous amount of data. Close to 700 patients were involved in these trials, so it's huge package."

Early data from two Phase III trials showed Herceptin slowed cancer and reduced tumor size. The company intends to provide more detailed results from the trials at a scientific meeting later this month. (See BioWorld Today, Dec. 23, 1997, p. 1.)

The drug was studied against metastatic cancer in patients who overexpress the HER2 oncogene. By binding to HER2 growth factor receptors especially abundant on the surfaces of cancer cells Herceptin neutralizes the receptors and slows tumor growth.

Genentech evaluated Herceptin's safety and efficacy in 469 women undergoing paclitaxel chemotherapy or anthracycline plus cyclophosphamide, as compared with treatment with either of those regimens alone. The patients had not previously been treated with chemotherapy.

The second trial studied Herceptin as a single agent in 222 women with metastatic breast cancer in whom HER2 was overexpressed. HER2 overexpression affects 25 to 30 percent of breast cancer patients, and is linked to faster progression and shortened survival rates.

As part of a separate, open-label safety trial, Genentech has been making the drug available to severely ill patients, chosen by lottery. One hundred patients receive the drug per quarter. The National Cancer Institute is taking over the lottery, Kennedy said.

Genentech's stock (NYSE:GNE) closed Monday at $68.50, down $0.437. *

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