gdc
Breast CancerFDA Approvals, News & UpdatesImmunotherapy

First Immunotherapy Approved for Patients with Advanced or Metastatic Triple-Negative Breast Cancer Expressing PD-L1

In March 2019, the FDA approved Tecentriq (atezolizumab), a PD-L1 inhibitor, in combination with Abraxane (paclitaxel protein-bound), for use in adults with locally advanced or metastatic triple-negative breast cancer whose tumors cannot be removed by surgery and express PD-L1, as identified by an FDA-approved test. This is the first FDA-approved immunotherapy for patients with advanced or metastatic triple-negative breast cancer.
April 2019 Vol 5 No 2
In March 2019, the FDA accelerated the ap­proval of the immunotherapy Tecentriq (atezol­izumab; from Genentech), a PD-L1 inhibitor, for use in combination with Abraxane (paclitaxel protein-bound; from Celgene) in adults with locally advanced or metastatic triple-negative breast cancer whose tumors cannot be removed by surgery (un­resectable) and express PD-L1, as identified by an FDA-approved test.

At the same time, the FDA approved the VENTANA PD-L1 (SP142) Assay, which is a companion diagnostic test used to identify patients with this type of breast cancer who are appropriate candidates for treatment with Tecentriq.

This approval was based on results of the clinical trial called IMpassion130, an international study that included 902 patients with unresectable, locally advanced or metastatic triple-negative breast cancer who had not received chemotherapy for metastatic disease. The VENTANA PD-L1 (SP142) Assay was used to identify patients whose tumors expressed PD-L1.

In patients whose tumors expressed PD-L1, the average time without cancer progression was 7.4 months for those who received Tecentriq in combination with Abraxane compared with 4.8 months among patients who received placebo plus Abraxane. Overall, 53% of the patients who received Tecentriq plus Abraxane responded to treatment compared with 33% of the patients who received Abraxane plus placebo.

The most common adverse reactions that occurred in 20% or more of patients with the immunotherapy plus chemotherapy combination included hair loss, peripheral neuropathies, fatigue, nausea, diarrhea, anemia, constipation, cough, headache, neutro­penia, vomiting, and reduced appetite. This approval represents the first time that the FDA approved an immune checkpoint inhibitor for the treatment of patients with triple-negative breast cancer.

Recommended For You
CholangiocarcinomaFDA Approvals, News & Updates
Pemazyre First Therapy Approved for Cholangiocarcinoma with FGFR2 Biomarker
On April 17, 2020, the FDA approved Pemazyre (pemigatinib; from Incyte)—an oral inhibitor of FGFR gene fusions or rearrangements 1, 2, and 3— for the treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma and the biomarker FGFR2 gene fusions.
Breast Cancer
Role of Biomarkers in Guiding Treatment for Breast Cancer
By Dana Taylor
Breast cancer is the second most common cancer among women, but it is important to remember that men can also have breast cancer. Recent advances in therapy have led to the discovery of specific biologic markers (biomarkers) in cancer cells, which has further led to the development of drugs known as targeted therapies.
Breast CancerFDA Approvals, News & Updates
Approved for Breast Cancer and HER2 Biomarker
On April 17, 2020, the FDA approved Tukysa (tucatinib; from Seattle Genetics), a kinase inhibitor, for use with chemotherapy (trastuzumab and capecitabine) for the treatment of adults with unresectable (cannot be removed by surgery) advanced or metastatic (spreading) HER2-positive breast cancer, after 1 or more previous treatments. Tukysa blocks the kinase enzyme, thereby blocking the growth of cancer cells.
Breast CancerPatient Stories
Public Health Professional Turned Patient: The Lives We Save May Be Our Own
By Sheree Marshall Williams, PhD
Sheree Williams, PhD, is a health scientist with the CDC, but her background in public health did not prepare her for the unique challenges she faced as a black woman diagnosed with breast cancer, highlighting the social determinants of health.
Last modified: April 30, 2019

Subscribe to CONQUER: the patient voice magazine

Receive timely cancer news & updates, patient stories, and more.

Country