FDA warns of lack of efficacy with atezolizumab plus paclitaxel
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FDA warns of lack of efficacy with atezolizumab plus paclitaxel The US FDA is alerting healthcare professionals that atezolizumab [Tecentriq] in combination with paclitaxel was not effective in a clinical trial in patients with inoperable locally advanced or metastatic triple-negative breast cancer (mTNBC). Although atezolizumab plus paclitaxel is not approved for the treatment of breast cancer in USA, atezolizumab in combination with albumen-bound paclitaxel [Abraxane] is approved for the treatment of mTNBC in adults whose tumours have been shown by an FDA-approved test to express PD-L1*. Continued approval of atezolizumab in combination with Abraxane may be contingent on evidence of benefit in clinical trials. Healthcare professionals are advised that they should not replace Abraxane with paclitaxel in clinical practice. In the randomised, double-blind, phase III IMpassion131 trial in patients with mTNBC, atezolizumab plus paclitaxel did not significantly reduce the risk of cancer progression or death compared with placebo plus paclitaxel in PDL1-positive patients, and paclitaxel plus placebo was favoured over atezolizumab plus paclitaxel in both the PDL1-positive subgroup and the total patient population in interim overall survival results. The FDA will communicate any potential changes to prescribing information after reviewing the findings of IMpassion131 and the effectiveness of atezolizumab plus paclitaxel in ongoing breast cancer trials. * programmed cell death-1 ligand-1 FDA. FDA alerts health care professionals and oncology clinical investigators about efficacy and potential safety concerns with atezolizumab in combination with paclitaxel for treatment of breast cancer Internet Document : 15 Sep 2020. Available from: URL: https://www.fda.gov/drugs/drug-safety-and-availability/fda-alerts-health-care803502471 professionals-and-oncology-clinical-investigators-about-efficacy-and
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Reactions 19 Sep 2020 No. 1822
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