Herceptin gets FDA ok for HER2 node

USA-based biotechnology major Genentech says that its anticancer agent Herceptin (trastuzumab) has been approved by the Food and Drug Administration as part of a combined regimen for the treatment of HER-2 positive, node-positive breast cancer. Specifically, the agency has approved the agent in combination with doxorubicin, cyclophosphamide and paclitaxel for the prevention of disease recurrence in women with localized breast cancer, who have received initial treatment.

The San Francisco-headquartered firm explained that the FDA's approval was primarily based on data from two Phase III clinical trials that examined Herceptin in more than 3,500 breast cancer patients. The results demonstrated that the product, as an addition to standard therapy, reduced the risk of recurrence by 52%, compared with those patients who received the standard treatment alone. In addition, the company revealed that, after three and a half years, 87% of those who were treated with Herceptin plus chemotherapy were disease-free, compared with 71% of the group that received chemotherapy only.

An external independent data monitoring committee reviewed the findings from each trial and determined that adverse cardiac events, most commonly congestive heart failure, were 3% to 4% more frequent in the group that received Herceptin and chemotherapy than those treated with chemotherapy alone.