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FDA Approvals, News & UpdatesLung Cancer

Tecentriq First Immunotherapy Approved for Adjuvant Treatment of Patients with Early-Stage NSCLC and PD-L1 Expression

On October 15, 2021, the FDA approved a new indication for Tecentriq (atezolizumab) for adjuvant (additional) treatment of patients with stage II-IIIA non–small-cell lung cancer and PD-L1 expression, after surgical removal of the tumor and chemotherapy. This is the first immunotherapy approved for patients with early-stage lung cancer.
November 2021 – Lung Cancer

On October 15, 2021, the FDA approved a new indication for Tecentriq (atezolizumab; from Genentech) for adjuvant (after surgery) treatment of patients with stage II to stage IIIA non–small-cell lung cancer (NSCLC) and PD-L1 expression  on ≥1% of the tumor cells (as determined by an FDA-approved test) after surgical removal of the tumor and platinum-based chemotherapy.

On the same day, the FDA also approved the VENTANA PD-L1 Assay as a companion diagnostic test to identify appropriate patients with early-stage NSCLC and PD-L1 expression for adjuvant treatment with Tecentriq.

This is the first immunotherapy approved for patients with early-stage NSCLC and PD-L1 expression. Currently, the immunotherapies approved for NSCLC are only approved for use in patients with advanced or metastatic NSCLC, or for patients with stage III NSCLC whose tumor cannot be removed by surgery or treated with radiation plus chemotherapy.

The FDA approved this new indication for Tecentriq based on the IMpower010 clinical trial of patients with stage IB to stage IIIA NSCLC. A total of 1,005 patients who had complete removal of the tumor by surgery and cisplatin-based adjuvant chemotherapy were included in the study and were divided into 2 groups to receive Tecentriq injection every 3 weeks for 16 cycles or best supportive care.

In patients who received Tecentriq, the average time of disease-free survival was not reached (meaning patients are still responding to treatment with this immunotherapy) compared with an average of 35.3 months in patients who received best supportive care.

The most common side effects with Tecentriq included some blood test abnormalities, rash, cough, hypothyroidism, fever, fatigue, musculoskeletal and joint pain, peripheral neuropathy, and itching.

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Last modified: December 15, 2021

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