On September 8, 2020, the U.S. Food and Drug Administration (FDA) announced it did not approve atezolizumab (Tecentriq®) in combination with paclitaxel for treatment of breast cancer after a clinical trial studying the use of atezolizumab and paclitaxel in patients with previously untreated inoperable locally advanced or metastatic triple negative breast cancer (mTNBC) showed the drug combination did not work to treat the disease.   

FDA Rejects Atezolizumab in Combination With Paclitaxel as Treatment for Breast Cancer 

However, atezolizumab in combination with paclitaxel protein-bound—a different combination therapy—is currently approved for the treatment of adult patients with mTNBC whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells of any intensity covering ≥ 1% of the tumor area), as determined by an FDA-approved test. Continued approval for atezolizumab in combination with paclitaxel protein-bound may be contingent on proven benefit of the treatment in additional trials.  

Healthcare professionals should not replace paclitaxel protein-bound with paclitaxel in clinical practice. 

Investigators in a phase III, multicenter, randomized, double-blind, placebo-controlled trial (IMpassion131) compared atezolizumab in combination with paclitaxel to placebo and paclitaxel for patients with mTNBC. 

Treatment with atezolizumab and paclitaxel did not significantly reduce the risk of cancer progression and death compared to placebo and paclitaxel in the PD-L1-positive population. Additionally, interim overall survival results favored paclitaxel and placebo over paclitaxel and atezolizumab in both the PD-L1-positive and total populations. 

View full prescribing information for atezolizumab

FDA will review its findings and communicate new information regarding the IMpassion131 results and any potential changes to prescribing information. FDA is also evaluating the use of atezolizumab and paclitaxel in ongoing clinical trials for breast cancer and will recommend additional changes as appropriate. 

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 800-FDA-1088.    

For assistance with single-patient oncology investigational new drug applications, contact the Oncology Center of Excellence’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov.