Roche’s Breast Cancer Drug Herceptin Gets Clearance in Japan

By Anna Boyd
16:50, February 29th 2008
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Roche’s Breast Cancer Drug Herceptin Gets Clearance in Japan

Japan’s health authorities have approved Roche’s cancer drug Herceptin for treatment of HER2-positive breast cancer, the Swiss drug maker said on Friday.

Herceptin is a humanized antibody designed to target and block the function of HER2, a protein produced by a specific gene with cancer-causing potential.

The approval was based on the impressive HERA (HERceptin Adjuvant) study results demonstrating that Herceptin significantly reduced the risk of death and recurrence by more than one third (34 percent and 36 percent respectively), in women with HER2-positive early-stage breast cancer when given following surgery and standard chemotherapy.

“It is most rewarding to see that Herceptin has improved the outlook for women with HER2-positive breast cancer in such a remarkable way and that its exceptional benefits are being recognised by health authorities across the world. We hope that all Japanese women suffering from this devastating disease will now be able to have access to Herceptin, a treatment that has been proven to offer the best chance for a cure,” William M. Burns, CEO of Roche's Pharmaceuticals Division said on the company’s website.

More than 1 million new cases of breast cancer are diagnosed worldwide, and nearly 400,000 people will die of the disease annually, the company said. HER2-positive breast cancer affects approximately 20 percent to 30 percent of women with breast cancer.

Herceptin is becoming more and more widely used to fight breast cancer, as it is now used on more than 450,000 patients worldwide.

Herceptin is marketed by Roche’s subsidiary Chugai Pharmaceuticals in Japan.



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