FDA Approves Genentech Drug for Breast Cancer
The Food and Drug Administration gave final approval Friday to Herceptin, a drug developed by Genentech Inc. to target an especially aggressive form of breast cancer.
Based on discoveries by UCLA scientists, the drug is being hailed as one of the first of a new class of therapies that will supplement surgery, chemotherapy and radiation in the treatment of malignancies.
“We now have a new weapon in our fight against breast cancer,” said Health and Human Services Secretary Donna Shalala in announcing the expedited approval, which came less than five months after Genentech submitted its final license application.
Said Dr. Michael A. Friedman, acting FDA commissioner: “The increasing use of biological products such as Herceptin to treat the underlying causes of diseases is an exciting development in medicine.”
Herceptin is a chemically altered version of a mouse antibody that specifically targets a protein, called HER2, that is excessively produced in tumor cells in 25% to 30% of women who have breast cancer. The FDA has approved use of the drug in combination with the drug Taxol in these women, whose tumors have spread beyond the breast. It will also be made available to patients with high HER2-expressing tumors who have not responded to chemotherapy. The drug is administered intravenously once a week.
While experts are careful to avoid describing the drug as a cure, extensive trials of the drug have shown that it can slow or even reverse tumor growth and increase survival when compared with chemotherapy alone. The drug, however, has not been shown to benefit cancer patients whose tumor cells produce only normal amounts of the HER2 protein.
Dr. Dennis Slamon, director of the Revlon/UCLA Women’s Cancer Research Program, whose discoveries led to development of the drug, said the approval shows that “if we understand what is broken in the malignant cell, we may be able to fix it.”
Anticipating the FDA action, Genentech has been building up its supplies of the product, which is made in its South San Francisco plant, and hopes to begin making it available to physicians by October.
Last November, federal regulators approved the first of these antibody treatments for cancer--the drug Rituxan, which Genentech is manufacturing in collaboration with IDEC Pharmaceuticals in San Diego. That drug is used in treating non-Hodgkin’s lymphoma and accounted for $35 million in revenue for Genentech in the second quarter of this year.
Kennedy estimated that there are about 164,000 women with metastatic breast cancer in the U.S., and about 50,000 will be candidates for Herceptin treatment. The company has not finalized a price for the product.
Wall Street analysts have long anticipated Herceptin’s approval, based on the results of positive clinical trials published in May and the recommendation of an FDA advisory panel last month. These analysts point out that Roche Holding Ltd., which now holds about 65% of Genentech stock, has the option to buy the balance at no more than $82.50 a share. That arrangement, part of a complicated buyout deal, has capped the price at that level until the option expires in June 1999.
Shares of South San Francisco-based Genentech rose $1.06 to close at $71.94 on the New York Stock Exchange.
