FDA issues alert about use of Tecentriq with paclitaxel for breast cancer
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The FDA alerted health care professionals and oncology researchers that a trial of atezolizumab plus paclitaxel did not appear effective for the treatment of patients with advanced triple-negative breast cancer.
The phase 3 IMpassion131 trial showed the addition of the anti-PD-L1 antibody atezolizumab (Tecentriq, Genentech/Roche) to paclitaxel did not significantly reduce the risk for cancer progression or death among PD-L1-positive patients with previously untreated inoperable locally advanced or metastatic triple-negative breast cancer.
Interim OS results from the trial favored the control regimen in the total study population and among PD-L1-positive patients, according to the alert.
Atezolizumab is approved in combination with paclitaxel protein-bound particles for injectable suspension (Abraxane, Celgene) — often called nab-paclitaxel — for the treatment of adults with metastatic triple-negative breast cancer whose tumors have greater than 1% PD-L1 expression as determined by an FDA-approved test. This approval may be contingent upon confirmatory trials.
Health care professionals should not replace nab-paclitaxel with paclitaxel in clinical practice, according to the alert.
Adverse events related to these drugs or similar products should be reported to FDA’s MedWatch Adverse Event Reporting program.
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