• Susan G. Komen Applauds FDA Accelerated Approval of First Immunotherapy for Treating Metastatic Breast Cancer

    New therapy option exciting advance in treating metastatic , triple negative breast cancer

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    Susan G. Komen applauded a ruling of the Food and Drug Administration (FDA) to provide accelerated approval of a new therapy to treat locally advanced or metastatic triple-negative breast cancer (TNBC) in people whose tumors express PD-L1, as determined by an FDA-approved test. This is the first targeted, immunotherapy treatment available for some people with metastatic triple negative breast cancers. 

    The FDA approval is for a combination of Roche’s immunotherapy drug Tecentriq® (atezolizumab) plus chemotherapy (Abraxane® [paclitaxel protein-bound particles for injectable suspension (albumin-bound); nab-paclitaxel]).  The approval was based on data from the IMpassion130 trial,a randomized phase III trial designed to test whether the treatment combination of the immune checkpoint inhibitor atezolizumab with standard chemotherapy could improve outcomes for patients with metastatic TNBC. Results from the study released late last year showed the combination treatment significantly reduced the risk of the disease worsening and improved overall survival in people with metastatic (stage IV) triple negative breast cancers that express the PD-L1 protein. 

    “This is a very exciting development as this is the first targeted immunotherapy for patients with metastatic, triple negative breast cancer,” said Victoria Wolodzko, Susan G. Komen’s Vice President of Mission. “This is the first of what we hope will be many new targeted therapies that utilize the body’s own immune system to fight breast cancer.”

    The FDA’s Accelerated Approval Program allows conditional approval of a medicine that fills an unmet medical need for a serious or life-threatening disease or condition.  Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

    While breast cancer is often referred to as a single disease, there are many subtypes.  Tumors that test negative for estrogen, progesterone and HER2 receptors are called Triple Negative Breast Cancers (TNBC).  TNBC is an aggressive form of the disease that previously lacked a targeted treatment option.  Metastatic breast cancer (also called stage IV or advanced breast cancer) is not a specific type of breast cancer, but rather the most advanced and deadly stage of breast cancer when it has spread beyond the breast to other organs in the body (most often the bones, lungs, liver or brain).