Aventis announced that the US FDA has approved Taxotere (docetaxel) Injection Concentrate in combination with doxorubicin and cyclophosphamide (TAC regimen) for the adjuvant (post surgery) treatment of patients with operable, node-positive breast cancer.
The supplemental New Drug Application (sNDA) received a Priority Review designation by the FDA, which is assigned to those applications that have the potential for providing a significant therapeutic advance. The additional indication also is under review by the European regulatory authorities, a company release said.
The FDA based its decision on results from a second interim analysis from the pivotal Breast Cancer International Research Group (BCIRG) 001/TAX 316 study, which demonstrated that women with node-positive, early stage breast cancer who received a Taxotere-based chemotherapy regimen (TAC) after surgery experienced a significant 25.7 per cent reduction in their risk of relapse (or the chance of their cancer returning) as compared to women treated with another adjuvant combination regimen of 5-fluorouracil, doxorubicin, and cyclophosphamide (FAC). Notably, with nearly five-years of follow-up (55 months), the significant reduction in the risk of relapse of this Taxotere-based regimen was observed regardless of a woman's hormone receptor status.
Additionally, at the time of this interim analysis, based on a total of 219 deaths, overall survival was longer for TAC than FAC (hazard ratio=0.69, 2-sided 95% CI=0.53, 0.90). There will be further analysis at the time survival data mature, the release added.
"The FDA approval of Taxotere in early stage breast cancer demonstrates the continued effectiveness of this agent across various stages of breast cancer," said Frank Douglas, executive vice president of Drug Innovation and Approval and a Member of the Board of Management at Aventis. "More importantly, the approval of Taxotere marks an important advance for women diagnosed with node-positive, early stage breast cancer, given the significant improvement in disease-free survival," he added.
"The nearly five-year follow-up data from the study suggest that by substituting Taxotere for 5-fluorouracil in a standard chemotherapy regimen in the adjuvant setting, we now have a treatment that may be able to benefit more women with early stage breast cancer," said Dennis Slamon, chairman of the BCIRG Scientific Committee and Director of Clinical and Transitional Research at UCLA's Jonsson Comprehensive Cancer Centre.
It is estimated that worldwide more than 300,000 women per year will be diagnosed with node-positive, early stage breast cancer. Most patients with early stage breast cancer (cancer localized to the breast with or without invasion of the lymph nodes under the arm) undergo surgery to remove the tumour. After surgery, most patients receive additional treatments, which may include chemotherapy to reduce the probability of tumour recurrence. Earlier diagnosis of breast cancer results in earlier treatment and may offer a better chance for cure.