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March 13, 2019

FDA approves first-ever immunotherapy for breast cancer

Daily Briefing

    FDA on Friday approved the first immunotherapy to treat advanced triple-negative breast cancer.

    Access the breast cancer dashboard to view tumor site-level data

    According to the National Breast Cancer Foundation, about one in 10 of all breast cancers are "triple-negative," which means their growth is not driven by estrogen, progesterone, or specific genes targeted by other cancer drugs, such as Herceptin. Triple-negative breast cancers do not respond to hormonal cancer treatments, and while they do respond to chemotherapy, researchers have found that cancer cells can develop resistance quickly and spread to other parts of the body.

    FDA approves first immunotherapy for breast cancer

    The immunotherapy, Roche's Tecentriq, is a PD-L1 inhibitor that helps the body's immune system detect and attack cancer. The drug, which costs approximately $13,400 per month, already has been approved to treat four other types of cancer, including non-small cell lung cancer and urothelial carcinoma.

    But the latest approval provides a new treatment option for triple-negative breast cancer patients who currently have limited options. FDA approved the immunotherapy for patients with locally advanced or metastatic triple-negative breast cancer who have the PD-L1 molecule that can block T cells from attacking a tumor.

    FDA said a clinical trial of 900 women showed modest benefits. Patients with triple-negative breast cancer who took Tecentriq in combination with chemotherapy on average went 7.2 months without their cancer worsening, compared with 5.5 months among patients who took a placebo in combination with chemotherapy.

    However, researchers have not yet finalized the data on whether Tecentriq improves overall survival. The latest data available from the trial show patients who took Tecentriq had a median survival of 25 months, compared with 15.5 month for patients in the placebo-chemotherapy group.

    Hope Rugo—a medical oncologist and breast cancer specialist at the University of California-San Francisco, who is involved in the research on Tecentriq—said, "We expect the final survival analysis this year," but added that researchers have "never seen anything that changes survival like that in triple-negative patients."

    In a press release, Genentech, the division of Roche that developed the immunotherapy, said continued FDA approval "may be contingent upon verification and description of clinical benefit in a confirmatory trial(s)."


    Amy Tiersten, a breast cancer specialist at Mount Sinai, called Tecentriq's approval for breast cancer "tremendously exciting news."

    Roche CMO Sandra Horning said, "FDA approval of this Tecentriq combination is an important treatment advance for people with PD-L1-positive, metastatic, triple-negative breast cancer, a disease with high unmet medical need. This Tecentriq combination is the first cancer immunotherapy regimen to be approved in breast cancer, representing a meaningful step forward in the understanding of this disease" (Johnson, Associated Press, 3/8; Dearment, MedCity News, 3/11; Begley, STAT News, 3/8; Mulcahy, Medscape, 3/8).

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