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FDA safety alert: Efficacy concerns for a combination therapy in breast cancer treatment
Officials from the Food and Drug Administration (FDA) issued a safety alert on Sept. 8 about potential efficacy and safety concerns with Tecentriq in combination with Paclitaxel for breast cancer treatment.
A clinical trial that studied the use of atezolizumab (Tecentriq)and paclitaxel versus a placebo and Paclitaxel to treat metastatic triple-negative breast cancer found that the combination therapy did not significantly reduce the risk of cancer progression and death when compared with placebo and paclitaxel in the PD-L1-positive population.
In addition, interim overall survival results favored paclitaxel plus placebo over paclitaxel plus atezolizumab in both the PD-L1-positive population and the total population.
The FDA urged that health care professionals should not replace paclitaxel protein-bound with paclitaxel in clinical practice.