The US Food and Drug Administration has approved a new drug, known as tucatinib or Tuksya, as a treatment for advanced forms of breast cancer. To be used alongside chemotherapy, it has been approved for cancer that cannot be removed by surgery, and that have spread to other parts of the body including the brain.
In particular, the drug works against HER2-positive breast cancer- when the body has an excessive amount of a cancer-growing protein known as human epidermal growth factor receptor 2 (HER2). Responsible for around 1 in 5 cases of breast cancer, around 25% of women with the condition also develop brain metastases.
The FDA approved Tuksya based on results from a controlled clinical trial examining its effects on 612 patients with treatment-resistant HER-2 positive breast cancer. In the end, the researchers found that patients who received the drug alongside chemotherapy and drugs trastuzumab and capecitabine had a progression-free survival (time in which the patient lives with the disease but it does not get worse) of 7.8 months compared to the 5.6 months of those on a placebo. Meanwhile, the overall survival and progression-free survival rate of those on the drug was 21.9 months as opposed to 17.4 months for those on the placebo.
The researchers also noted that common side effects of the drug are diarrhea, palmar-plantar erythrodysesthesia (burning or tingling discomfort in the hands and feet), nausea, liver damage, decreased appetite and anemia among others. Meanwhile, they noted that serious side effects included severe diarrhea, acute kidney injury and death.
"We recognize that patients with cancer constitute a vulnerable population at risk of contracting the coronavirus disease," says Dr. Richard Pazdur, director of the FDA’s Oncology Center of Excellence. "In this critical time, we remain steadfast in our commitment to patients with cancer and doing everything we can to expedite oncology product development. Tukysa was approved four months prior to the FDA goal date, providing an example of this commitment and showing how our regular work in reviewing treatments for patients with cancer is moving forward without delay."