FDA OKs Drug's Expanded Role
By Staff & AP Reports
Work continues on the $600 million expansion at Genentech's Vacaville manufacturing facility. (Courtesy photo)
The breast cancer drug Herceptin - one of the drugs manufactured at Genentech's Vacaville facility - received expanded federal approval Thursday to include treatment of some women after they have undergone surgery.
In two clinical trials, women given the drug along with chemotherapy had fewer relapses in the three years after surgery - either to remove a lump or the whole breast - than those just given standard chemotherapy, the Food and Drug Administration said in announcing the additional approval.
Frank Jackson, vice president and general manager of Vacaville product operations, has told The Reporter that the positive results and growth of products such as Herceptin, "is driving demand for additional manufacturing capacity from Genentech, and Vacaville's role is to be a significant supplier for these extra runs." The Vacaville plant is currently undergoing an expansion that will greatly increase its manufacturing capacity.
Herceptin is only for the estimated 20 percent of patients whose breast tumors churn out too much of a protein known as HER-2. About 50,000 women in the United States and 250,000 worldwide are diagnosed with this type, called HER-2 positive, each year.
In 1998, the FDA approved Herceptin to treat breast cancer after it had spread to other parts of the body. Thursday's approval expands its use to women with cancer in the breast or lymph nodes that has been surgically removed, the FDA said.
The most serious side effect of Herceptin is heart failure. Only patients with HER-2 positive tumors, and who do have heart failure or a weak heart, should be given the drug, also known as trastuzumab.
