FDA Approves Tecentriq plus Abraxane—First Immunotherapy for PD-L1– Positive Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer

Web Exclusives - FDA Approvals, In the News
Yvette Florio Lane

On March 8, 2019, the FDA granted accelerated approval to Genentech’s Tecentriq (atezolizumab), in combination with nab-paclitaxel (Abraxane), for the treatment of PD-L1–positive unresectable locally advanced or metastatic triple-negative breast cancer (TNBC). This marks the first time an immunotherapy drug has been granted approval for the treatment of any form of breast cancer.

This indication was granted accelerated approval based on data from the phase 3 IMpassion130 study, a multicenter, international, double-blind, placebo-controlled, randomized trial of 902 patients with unresectable locally advanced or metastatic TNBC who had not received prior chemotherapy for metastatic disease. In this study, the median progression-free survival for patients with PD-L1–positive tumors treated with atezolizumab plus nab-paclitaxel was 7.4 months versus 4.8 months for those treated with nab-paclitaxel plus placebo.

The most common side effects (reported in ≥20% of patients) were hair loss, fatigue, numbness or tingling in the hands and feet, nausea, diarrhea, low red blood cell count, constipation, cough, headache, low white blood cell count, decreased appetite, and vomiting.

This is the fifth approval for the PD-L1 inhibitor Tecentriq, which has been approved for use in the treatment of some forms of lung cancer, bladder cancer, and urothelial cancers.

Breast cancer is the most common female cancer worldwide. According to the American Cancer Society, approximately 271,000 people in the United States will be diagnosed with breast cancer in 2019. Of those, approximately 15% will be diagnosed with TNBC, an aggressive form of the disease with few treatment options.

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).

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Last modified: March 15, 2019
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