NBCC Petitions Genentech: Do What’s Best for Women

[Paula O]

Copied from http://www.breastcancerdeadline2020....html#herceptin

Call to Action Online - November 2012

November 2012
NBCC Petitions Genentech: Do What’s Best for Women

In early October, the National Breast Cancer Coalition (NBCC) led the effort to petition Genentech to do the right thing and change how women with breast cancer are treated. We told them it was time to usher in a new era of treatment and stop subjecting women to unnecessary toxicities, through the design of the clinical trials in early breast cancer for T-DM1. More than 40 groups signed on, and others continue to join, urging Genentech to act in the best interest of women.

Why now? T-DM1 is not a new drug, but rather a novel combination of two existing drugs, the targeted therapy trastuzumab (Herceptin) and a potent chemotherapy drug called emtansine, or DM1, linked so the chemotherapy is delivered directly to the cancer cells with seeming minimal effect on healthy cells. If the clinical trials in early breast cancer for T-DM1 include an arm without systemic chemotherapy we can find out if women could receive both targeted therapy and a chemotherapy agent, with minimal systemic effect and at least equivalent efficacy. What would that mean? Fewer serious and sometimes life-threatening toxicities that accompany systemic chemotherapy.

NBCC helped with the pivotal trial for Herceptin back in the 1990s, in part due to the promise of less toxicity from targeted therapy. Because chemotherapy hits all cells and not just cancer cells women were subjected to significant, serious and at times life-threatening toxicities. Targeted therapy was supposed to change that. The promise was not fulfilled because Herceptin is given with systemic chemotherapy, so that toxicity is added rather than minimized. Early trials for T-DM1 showed improved overall survival by close to six months for women with metastatic breast cancer. The next step is to test it with women who have early stages of breast cancer.

After conversations with the company and the FDA, NBCC presented the case for an updated design for the trial, as well as the case against one type of chemotherapy called anthracyclines. The conversation around clinical trials and breast cancer research needs to be changed to focus on what is best for women and what will ultimately save lives. There is more to do on that front, but NBCC continues to lead the way.