FDA Approves First Immunotherapy for Breast Cancer
The US Food and Drug Administration approved first immunotherapy drug for Triple-Negative Breast Cancer
Until recently, women with inoperable triple-negative breast cancer had one treatment option: chemotherapy. In March, FDA granted accelerated approval to the first immunotherapy treatment for breast cancer. It combines the drug Atezolizumab (Tecentriq, Genentech/Roche)) with a form of chemotherapy nab-paclitaxel (Abraxane, Celgene) for the first-line treatment of unresectable locally advanced or metastatic, PD-L1-positive triple-negative breast cancer(TNBC).
This is good news, because the drug garnered the first positive phase 3 trial for an immunotherapy drug to treat breast cancer. The treatment was also first to show a substantial survival benefit for women with triple-negative breast cancer, one of the most aggressive forms of the disease.
The approval is based on progression-free survival results and continued approval may be contingent upon confirmatory trial data.
The approval of the combination is based on safety and efficacy results from the multicenter IMpassion130 trial, which were presented at the European Society for Medical Oncology (ESMO) 2018 Congress and published in the New England Journal of Medicine.
The trial randomly assigned 451 patients with locally advanced or metastatic triple-negative breast cancer patients to atezolizumab and 451 to placebo. All 902 patients also received nab-paclitaxel.
The therapy extended progression-free survival, which refers to a duration of time in which a person’s cancer doesn’t worsen. Those who used the drug had a median progression-free survival of 7.4 months compared to 4.8 months for those who only received the chemotherapy with a placebo.
“This is the first time immunotherapy has worked in such a difficult-to-treat cancer,” told Dr. Pete Schmid, PhD, one of the researchers from Queen Mary University of London, in his statement to Healthline. Dr Schmid said more research is needed to see if the drug could work on other types or earlier stages of breast cancer.
The brand name of the immunotherapy drug atezolizumab is Tecentriq and it has already been approved to treat specific types of urinary and lung cancers.