Results of clinical study showed an increase in progression-free survival with new treatment
The FDA recently approved a new therapy for patients with HER2-positive, metastatic breast cancer who had previously received treatment with trastuzumab and taxanes.
Kadcyla (ado-trastuzumab emtansine) was reviewed under the FDA’s priority review program.
According to Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, “Kadcyla is trastuzumab connected to a drug called DM1 that interferes with cancer cell growth.”
In a clinical study of 991 patients, the safety and effectiveness of ado-trastuzumab emtansine, referred to as T-DM1 during clinical research, were assessed. Study participants were randomly treated with either ado-trastuzumab emtansine or lapatinib plus capecitabine.
Study results showed that patients who received ado-trastuzumab emtansine had a median progression-free survival of 9.6 months versus 6.4 months for patients treated with lapatinib plus capecitabine.
The following side effects were commonly associated with ado-trastuzumab emtansine: constipation, fatigue, headache, increased levels of liver enzymes, nausea, pain in the muscles or joints, and thrombocytopenia.
Source: FDA.