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

Web Exclusives - FDA Updates, In the News

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).

Related Items
FDA NEWS: February 28, 2022 to March 31, 2022
TOP - May 2022 Vol 15, No 3 published on May 6, 2022 in FDA Updates
FDA NEWS: January 10, 2022, and January 25, 2022
TOP - March 2022 Vol 15, No 2 published on March 16, 2022 in FDA Updates
FDA NEWS: November 29, 2021, and December 15, 2021
TOP - January 2022 Vol 15, No 1 – Online Only published on January 20, 2022 in FDA Updates
FDA NEWS: August 13, 2021 to September 22, 2021
TOP - November 2021 Vol 14, No 7 published on November 10, 2021 in FDA Updates
FDA Issues Revised Final Guidance on Biosimilar Development and the BPCI Act
TOP - October 2021 Vol 14, No 6 | Biosimilars published on November 5, 2021 in FDA Updates, Biosimilars
FDA NEWS: June 30, 2021, and July 26, 2021
TOP - September 2021 Vol 14, No 5 published on September 7, 2021 in FDA Updates
FDA NEWS: May 5, 2021 to May 28, 2021
TOP - July 2021 Vol 14, No 4 published on July 20, 2021 in FDA Updates
FDA NEWS: April 13, 2021 to April 23, 2021
TOP - May 2021 Vol 14, No 3 published on May 14, 2021 in FDA Updates
FDA NEWS: February 5, 2021 to February 22, 2021
TOP - March 2021 Vol 14, No 2 published on March 11, 2021 in FDA Updates
FDA News: November 25th To December 18th
TOP - January 2021 Vol 14, No 1 published on February 9, 2021 in FDA Updates
Last modified: July 22, 2021