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18-09-2020 | FDA | News

Regulatory update

FDA issues alert on atezolizumab–paclitaxel duo in breast cancer

Shreeya Nanda

medwireNews: The US FDA has released a safety alert regarding the use of atezolizumab alongside paclitaxel in light of data indicating a potential survival detriment from the IMpassion131 study of the combination in treatment-naïve triple-negative breast cancer (TNBC).

The PD-L1 inhibitor given in combination with nab-paclitaxel is currently approved for metastatic TNBC patients with PD-L1-positive disease, and the FDA stresses that healthcare providers should not replace nab-paclitaxel with paclitaxel for this indication.

The agency adds, however, that “[p]atients taking atezolizumab and paclitaxel for other approved uses should continue to take their medication as directed by their health care professional.”

As stated in the alert, the addition of atezolizumab to paclitaxel in the phase 3 IMpassion131 trial did not significantly improve progression-free survival versus placebo plus paclitaxel, and overall survival was numerically worse in the atezolizumab arm.

“[The] FDA will review the findings of IMpassion131 and will communicate new information regarding the IMpassion131 results and any potential changes to prescribing information,” says the agency, which also intends to evaluate “the use of atezolizumab and paclitaxel in ongoing clinical trials for breast cancer and will recommend additional changes as appropriate.”

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