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FDA approves Tarceva anti-cancer combo
Lung cancer drug from Genentech, OSI gets green light to treat pancreatic cancer with chemo.
November 3, 2005: 9:52 AM EST
By Aaron Smith, CNN/Money staff writer

NEW YORK (CNN/Money) - The Food and Drug Administration approved the combined use of Tarceva, an anti-cancer drug from Genentech and OSI Pharmaceuticals, with chemotherapy to treat pancreatic cancer, the companies said.

On Wednesday, the FDA approved Tarceva's use with gemcitabine chemotherapy, which is used to stop the spread of cancer cells. Tarceva, a once-a-day pill, was approved by the FDA in November, 2004, to treat non-small cell lung cancer, a disease in which malignant cancer cells form in lung tissue. The drug-chemotherapy combo is approved to treat pancreatic cancer, the fourth leading cause of cancer death in the United States, killing some 32,000 people per year.

Tarceva, also known as erlotinib, is the flagship drug of OSI (down $0.21 to $23.52, Research), a biotech based in Melville, NY, and is also developed by South San Francisco-based Genentech (up $1.05 to $92.80, Research), the second-largest biotech. Tarceva's U.S. sales totaled $73 million in the third quarter of 2005.

The FDA approval came as no surprise, because in September the regulatory agency's advisory panel voted 10-3 to recommend the Tarceva combo for approval. The FDA follows the advice of its panels most of the time.

Also in September, Genentech unveiled data for another drug-chemo combo with its profitable breast cancer drug Herceptin, which showed a reduced risk in causing heat failure compared to its previous studies. The data involved a new mix of chemotherapies, including Taxotere from French drug maker Sanofi-Aventis (up $0.20 to $39.98, Research), used to halt the spread of early-stage breast cancer after tumors are removed. Genentech said that Herceptin's U.S. sales totaled $215 million in the third quarter of 2005, a 70 percent surge from the same period the previous year.


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