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FDA Approves First Immunotherapy for Breast Cancer

The U.S. Food and Drug Administration (FDA) has granted accelerated approval for the first immunotherapy treatment for breast cancer. Tecentriq (atezolizumzb) combined with the chemotherapy medicine Abraxane (nab-paclitaxel) will be a new treatment option for patients with triple-negative breast cancer (TNBC) who have unresectable (non-operable) advanced or metastatic breast cancer. To be eligible, patients must have not received prior chemotherapy treatment for metastatic disease.1,2

With accelerated approval, the FDA grants conditional acceptance of medicine that addresses unmet medical needs for a serious or life-threatening disease or condition.2 Approval is based on results from the Phase III IMpassion 130 study. The data report a reduced risk of disease worsening or death. Immunotherapy provides individualized treatment tailored to the immune system improving the ability to fight cancer.2

Triple-negative breast cancer

Breast cancer is the most common cancer in women with over 270,000 cases anticipated to be diagnosed in 2019.2 There are many different kinds and preferred treatments vary for each. In triple-negative breast cancer, tumor cells are missing specific hormone receptors; they are ER-negative (estrogen), PR-negative (progesterone), and HER2-negative (human epidermal growth factor receptor 2).

According to the Triple-Negative Breast Cancer Foundation, this form of breast cancer is often aggressive and difficult to treat.2 About 10-20% of all breast cancers are triple-negative. Up until now, chemotherapy has been the primary treatment for cases where tumors express PD-L1.2 FDA approved tests are used to evaluate the PD-L1+. Tecentriq is manufactured by Genentech, a part of the Roche Group. Abraxane is made by Abraxisis Bioscience, a subsidiary of Celgene.2,3 Genentech has been involved in breast cancer research for more than 30 years.2

Approval based on research

Tecentriq plus nab-paclitaxel is a new regimen. A monoclonal antibody, Tecentriq can bind with PD-L1 proteins expressed on tumor cells and tumor-infiltrating immune cells, blocking interactions with receptors. By inhibiting PD-L1, Tecentriq may influence the reactivation of T cells as well as affecting normal tissue.2 These changes can lead to serious problems.

FDA approval is based on data from clinical trials. The safety profile of the new combination drug was consistent with the individual medication safety profiles.1,2 The IMpassion130 trial looked at 902 patients, all of whom received nab-paclitaxel. Half of those also received Tecentriq, and half were given a placebo. Those on Tecentriq experienced significantly reduced disease progression and death.3 According to the lead author of the study, Dr. Peter Schmid, for those in the Tecentriq subgroup, results yielded nearly a 10 month longer survival.3

Ongoing study and treatment data will be shared with the FDA. Continued approval determinations will be made based on verification of treatment benefits from ongoing/confirmatory trials.1,2

Dosing

In the trial, Tecentriq was administered by injection for intravenous (IV) infusion at a dose of 840 mg over 1 hour on days 1 and 15 of each cycle, which last 28 days. The drug, which comes as a sterile, preservative-free, colorless to slightly yellow solution in single-dose vials, was given until there was evidence of disease progression or unacceptable levels of toxicity. The co-administered nab-paclitaxel had a starting dose of 100 mg/m2 via IV infusion over 30 minutes on days 1, 8, and 15 of the same cycle.2-4

Possible side effects of Tecentriq and nab-paclitaxel

The most common side effects of Tecentriq in people with breast cancer are hair loss, fatigue, nausea, diarrhea, tingling in the hands and feet, headache, vomiting, infusion reactions, low white blood cell count, low red blood cell count, cough, constipation, and decreased appetite.2

Important things to know about Tecentriq

Serious side effects are possible when taking Tecentriq. Tell your doctor right away if you experience:

  • Lung problems
  • Liver problems
  • Intestinal problems
  • Hormonal gland problems
  • Infection or infusion reactions

This is not a complete list of all possible side effects. As when starting any new drug, discuss in advance with your doctor all medications, supplements, and vitamins before taking.

  1. Nessel, J. FDA OKs First Immunotherapy Combo Regimen for Breast Cancer. Available at: https://www.pharmacytimes.com/news/fda-oks-first-immunotherapy-combo-regimen-for-breast-cancer. Accessed 3.8.19.
  2. FDA Grants Genentech's Tecentriq in Combination With Abraxane Accelerated Approval for People With PD-L1-Positive, Metastatic Triple-Negative Breast Cancer [news release]. Available at: https://www.gene.com/media/press-releases/14782/2019-03-08/fda-grants-genentechs-tecentriq-in-combi. Accessed March 8, 2019.
  3. Mulcahy, N. FDA Approves First Immunotherapy for Breast Cancer. Available at: https://www.medscape.com/viewarticle/910121?nlid=128531_3901&src=wnl_newsalrt_190308_MSCPEDIT&uac=285690FR&impID=1903108&faf=1. Accessed 3.8.19.
  4. Tecentriq prescribing information. Available at: https://www.tecentriq-hcp.com/triple-negative-breast-cancer.html. Accessed 3.8.19.

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