Roche asks European regulators to approve early-stage breast-cancer drug Herceptin

By Elaine Rigoli

Tampa, Fla., Feb. 16 - Roche announced Thursday the submission of a Marketing Authorization application to the European Medicines Agency for Herceptin (trastuzumab) as adjuvant treatment for early-stage HER2-positive breast cancer.

The application is based on data from the international HERA (HERceptin Adjuvant) study that showed that Herceptin following standard chemotherapy reduces by 46% the risk of cancer returning.

Genentech, Inc. filed a similar license extension for Herceptin in the United States just two days before the European filing. The application is based on data from a combined interim analysis of two large U.S. trials, and Genentech has requested a priority review designation, according to a company release.

Herceptin is marketed in the United States by Genentech, in Japan by Chugai and internationally by Roche. Since 1998, Herceptin has been used to treat more than 230,000 HER2-positive breast cancer patients worldwide.

Herceptin received approval in the European Union in 2000 for use in patients with metastatic breast cancer, whose tumors overexpress the HER2 protein.

HER2-positive breast cancer, which affects approximately 20% to 30% breast cancer patients, demands special and immediate attention because HER2-positive tumors are fast growing. Results from four large trials, with nearly 12,000 patients analyzed around the globe, provide consistent evidence that Herceptin reduces the risk of cancer coming back by about half, providing the best chance of long-term survival to women with this aggressive form of early-stage breast cancer, according to a company news release.

"The outstanding benefits we have seen from Herceptin as post-surgical therapy for early-stage breast cancer underpin the importance of securing patient access to this drug as quickly as possible," commented Ed Holdener, head of Roche's Global Pharma Development, in a company release.

HERA, conducted by the Roche and Breast International Group, is one of the largest adjuvant studies ever carried out among breast cancer patients; enrollment for the trial began in December 2001, and nearly 5,100 HER2-positive patients were enrolled at 480 sites in 39 countries across the world, according to a company news release.

The HERA study allowed for the use of a wide range of chemotherapy regimens, and both lymph node-positive and lymph node-negative patients were eligible for entry into the trial.

Headquartered in Basel, Switzerland, Roche is a research-focused health care group in the fields of pharmaceuticals and diagnostics.

Genentech, a biotechnology company that develops biotherapeutics, has headquarters in South San Francisco, Calif.

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