The FDA approved a new drug for advanced breast cancer on Friday, February 22, and Georgia Cancer Specialists (GCS) played an important role in the clinical trial that led to its approval.
T-DM1 (Kadcyla) is approved for metastatic HER2-positive breast cancer patients whose disease has progressed following treatment with Herceptin and a taxane chemotherapy drug, such as paclitaxel. It prolongs median survival by an average of six months.
HER2-positive disease accounts for nearly 20% of all breast cancers.
T-DM1–which combines the popular breast cancer drug Herceptin with a powerful toxin–is an example of a new class of drugs that link toxins to proteins known as monoclonal antibodies. The antibody Herceptin in this case targets the tumors and delivers the toxic payload thus killing the tumor cells., Since the toxin is not released until it reaches the tumor, healthy cells are spared and many side effects are avoided.
GCS began participation in the study in 2009 via the EMILIA trial, an open-label study of T-DM1 vs. capecitabine plus lapatinib in patients with HER2-positive locally advanced or metastatic breast cancer.
GCS Director of Clinical Research Dr. Mansoor Saleh said the study showed how a cancer drug can enter the body like a smart bomb to attack and kill only cancer cells without damaging healthy cells.
“It is a dramatic ray of hope, a new drug that did not exist before. To us in the scientific field, we now can deliver–chemotherapy in this case–T-DM1 directly to the enemy, i.e. the tumor cell, and not harm the rest of the tissue,” Dr. Saleh said.
Georgia Cancer Specialists was also recently selected to be part of the upcoming trial designed to test T-DM1 in the front line setting.
Georgia Cancer Specialists is a Top 10 private cancer practice in the U.S. and a leader in advanced cancer treatment and research. The practice supports more than 150,000 patient visits each year. GCS offers community-based medical oncology and hematology services and is the first private oncology practice to also provide a full range of support services for patients in Georgia. GCS physicians were the first in Georgia to offer Phase I clinical trials, the most novel cancer therapies available. GCS 46 medical oncologists practice in 27 locations in Metro Atlanta, and North and Central Georgia. Georgia Cancer Specialists can be found on the web at www.gacancer.com. GCS is The Cancer Answer®.