ROCKVILLE, Md.-The FDA has approved an MAB for metastatic breast-cancer patients who overproduce HER2.
Trastuzumab (Herceptin, Genentech) was indicated as monotherapy for patients with excess expression of HER2 who have failed chemotherapy. It was also okayed as a treatment for metastatic disease, combined with paclitaxel (Taxol, Bristol-Myers Squibb).
In a clinical trial of 469 patients with metastatic disease, the median time to disease progression was 7.2 months with chemotherapy plus trastuzumab, vs. 4.5 months for those getting chemotherapy alone. The overall tumor response was 45% in the MAB group, compared with 29% in the chemotherapy patients. One-year survival was 79% vs. 68%.
Trastuzumab carries a warning against use with anthracyclines. -Judith Groch
