Here's Dow Jones on Herceptin:
Genentech's Herceptin Popular Topic at ASCO meeting
By Otesa Middleton
LOS ANGELES (Dow Jones)--More than 5,000 doctors at the American Society of Clinical Ongology annual meeting here turned out to hear San Francisco-based biotechnology company Genentech Inc. (GNE) discuss results of its breast cancer study.
Sunday evening, Genentech drew more than a quarter of the conference's almost 19,000 attendees to its presentation on its drug Herceptin, which studies show slows progression of the cancer and shrinks tumors.
The company May 4 submitted its application to the U.S. Food and Drug Administration, which designated the drug for fast-track review; that generally means a ruling within six months.
Herceptin is designed to treat one aggressive form of breast cancer - in particular, that marked by an increase in production of a protein called HER2. About 25% to 30% of all patients with breast cancer produce a large amount of the protein.
"These women had a more aggressive form of the disease," said Dr. Dennis Slamon of the University of California, Los Angeles School of Medicine and principal investigator of Herceptin. "We found it made tumors grow rapidly."
In patients with normal HER2, the median survival from the time of diagnosis is six to seven year. For patients with an overabundance of HER2, median survival is just half that.
Genentech's Phase III study of Herceptin looked at 469 breast cancer patients who showed an overexpression of HER2. It compared standard chemotherapy alone to standard chemotherapy plus Herceptin, and showed tumors in patients who received Herceptin progressed slower.
The median time to progression in patients receiving Herceptin was 7.6 months, compared to 4.6 months for patients who got chemotherapy alone. Of patients who received Herceptin, 49% showed a partial response rate, compared to 32% of patients on chemotherapy alone.
Partial response is defined as at least a 50% decrease in tumor size.
Genentech also studied Herceptin alone in 222 patients with spreading breast cancer, who showed an overexpression of HER2 and had relapsed after one or two chemotherapy regimens. Of those patients, 16% responded to the treatment.
The most common adverse reactions to Herceptin were chills and fever. Hair loss, mouth sores and low blood cell count levels, which occur often in women undergoing chemotherapy, weren't seen commonly among women taking Herceptin alone.
Women taking Herceptin and anthracyclines at the same time had an increased risk of cardiac dysfunction.
About 180,300 new breast cancer cases are expected in the U.S. this year.
Genentech provides Herceptin through a lottery program on an expanded access basis, which allows the company to distribute the drug for free before FDA approval.
About 100 women per quarter are chosen to receive the drug through a computerized lottery conducted by the National Cancer Institute.
-Otesa Middleton 202-862-6654 |
