Latest Genentech breast cancer drug, T-DM1, faces FDA decision by Feb. 26

Genentech Inc.'s experimental cancer drug T-DM1 is heading for a Feb. 26 decision date with the Food and Drug Administration.

The South San Francisco-based U.S. subsidiary of Switzerland's Roche Group said Tuesday that the FDA accepted the company's application for T-DM1, or trastuzumab emtansine, for use by women with HER2-positive metastatic breast cancer. By giving the drug "priority review," the FDA will cut four months off its review time, bringing its decision date on approval to Feb. 26.

Genentech fires new shot at breast cancer

A “smart bomb” that targets breast cancer cells while minimizing collateral damage to healthy cells is pushing Genentech Inc. toward its fourth cancer drug approval in 18 months. Trastuzumab emtansine, or T-DM1, which the South San Francisco-based U.S. subsidiary of drug giant Roche AG submitted to the Food and Drug Administration in August, could be approved by the end of February. That timeline is good news for patients, some of whom have pushed the FDA to speed approval of the drug, which piggybacks a chemotherapy agent by ImmunoGen Inc. onto Genentech’s long-running cancer drug Herceptin.

Genentech seeks approval of 'armed antibody' targeting breast cancer

Genentech Inc.’s one-two cancer-fighting punch – an antibody-drug conjugate called T-DM1 – extended the lives of women with a type of metastatic breast cancer compared to patients on another therapy, the South San Francisco-based company said Sunday. Genentech, the U.S. subsidiary of Swiss drug maker Roche, did not disclose a specific length of time by which T-DM1, or trastuzumab emtansine, extended the lives of HER2-positive metastatic breast cancer patients over a group of patients given a combination of the drugs Tykerb and Xeloda. Genentech said it has submitted a biologics license application, which is similar to a new drug application, for T-DM1 to the Food and Drug Administration. An FDA decision on the drug could come by mid-2013. The agency in 2010 refused to consider Genentech’s application for accelerated approval based on data from a Phase II study.

Genentech antibody-chemo punch strong in breast cancer trial

A mid-stage trial of a highly selective version of Genentech Inc.’s blockbuster cancer-fighting drug Herceptin found that metastatic breast cancer patients lived a median of five months longer without their disease worsening.
South San Francisco-based Genentech and its Swiss parent Roche said a Phase II trial found that patients using the antibody-drug conjugate — called trastuzumab emtansine, or T-DM1 —saw a 41 percent reduction in the risk of death or of their disease worsening.