Genentech Inc. (DNA) said Thursday that it won Food and Drug Administration approval for its drug Herceptin to treat early-stage, HER2-positive breast cancer.
Herceptin is currently approved in the U.S. to treat advanced HER2-positive breast cancer, an aggressive form of the disease found in women who test positive for a protein known as HER2.
It is estimated that about 200,000 women are diagnosed with the breast cancer per year. Of those, about 25% are HER2-positive.
Approval came nine months after the South San Francisco, Calif., biotechnology company filed the request with the FDA. The agency was set to issue a decision in August, but it opted to extend the deadline after it requested additional information from the company.
"We believe that this (approval) represents such an enormous improvement for women with breast cancer," David Schenkein, the company's vice president of clinical hematology and oncology, told Bulresearch.
Schenkein said the company submitted the application based on results from two trials involving a total of 3,500 women with early, HER2-positive breast cancer. The primary endpoint was risk reduction for recurrence of the disease.
According to him, recurrence risk was cut by more than half with Herceptin, "which actually represents perhaps the largest improvement in outcome for women with breast cancer in 25 years." Schenkein also said the drug improved overall survival.
U.S. sales of Herceptin were of $747.2 million for 2005 and $912 million for the nine months ended Sept. 30. Genentech said in its latest quarterly report that increased sales of the drug this year are attributed to facts including off-label use for treatment of early-stage HER2-positive breast cancer.
A company spokeswoman declined to provide revenue expectations with the new FDA approval.
In Europe, where Herceptin is sold by Genentech parent company Roche Holding AG (RHHBY), the treatment gained approval for patients with early-stage HER2-positive breast cancer in May.
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