麻豆传媒

The FDA approved the as adjuvant treatment following surgery and platinum-based chemotherapy for stage II-IIIa non-small cell lung cancer (NSCLC) that expresses PD-L1.

The new approval makes atezolizumab the first immunotherapy to get an adjuvant indication for NSCLC, drugmaker Roche announced.

"Too many patients with early-stage lung cancer experience disease recurrence following surgery," said Bonnie Addario, chair of the GO2 Foundation for Lung Cancer, in a . "Now the availability of immunotherapy following surgery and chemotherapy offers many patients new hope and a powerful new tool to reduce their risk of cancer relapse. With this approval, it is more important than ever to screen for lung cancer early and test for PD-L1 at diagnosis to help bring this advance to the people who can benefit."

Support for the approval came from the IMpower010 randomized trial. Among patients with PD-L1 expression ≥1%, those who received atezolizumab after surgery and chemotherapy, as opposed to best supportive care, had a 34% reduction in the risk of disease recurrence or death.

The study produced no new safety issues, as adverse events (AEs) were consistent with those known to be associated with atezolizumab. Fatal and serious AEs occurred in 1.8% and 18%, respectively, of patients treated with atezolizumab. The most frequent serious AEs associated with atezolizumab were pneumonia (1.8%), pneumonitis (1.6%), and pyrexia (1.2%).

The approval in the adjuvant setting brings the number of approved indications for atezolizumab in lung cancer to six. Before now, only osimertinib (Tagrisso) had been approved as adjuvant therapy for NSCLC following surgery and standard chemotherapy, but only for patients harboring EGFR mutations.

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