New Breast Cancer Indication for Tecentriq
March 11, 2019 – The U.S. FDA has approved a new indication for Tecentriq® (atezolizumab), manufactured by Roche, as part of the first immunotherapy regimen approved for breast cancer. Under the new indication, Tecentriq can be used in combination with chemotherapy (Abraxane® [paclitaxel protein-bound particles for injectable suspension (albumin-bound); nab-paclitaxel]) to treat adults who have unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) and whose tumors express PD-L1, as determined by an FDA-approved test.
Approximately 15% of all breast cancers are TNBC, which is determined by a lack of amplification and/or lack of expression of targetable receptors for estrogen, progesterone, and HER2 amplification. TNBC is generally more common, compared to other forms of breast cancer, in women who are less than 50 years old. The disease is aggressive, with more rapid progression and poorer overall survival compared to other types of breast cancer.
Approval for Tecentriq’s new indication is based on the results of clinical studies in which treatment with Tecentriq and Abraxane reduced the risk of disease progression or death by 40% in newly diagnosed patients compared to the use of Abraxane alone. Median progression free survival with Tecentriq and Abraxane was 7.4 months versus 4.8 months when only Abraxane was used.
Recommended dosing is 840mg of Tecentriq given via intravenous (IV) infusion over the course of 60 minutes, followed by the administration of 100mg/m2 of Abraxane. Tecentriq is administered on the first and fifteenth days of a 28-day cycle, while Abraxane is administered on the first, eighth, and fifteenth days. If Tecentriq is tolerated, infusion time can be reduced to 30 minutes after the initial dose.
Tecentriq first received FDA approval in 2016. It is also indicated to treat urothelial carcinoma, non-small cell lung cancer, and extensive-stage small cell lung cancer.