The US Food and Drug Administration (FDA) has approved Roche’s Tecentriq or atezolizumab as adjuvant treatment for patients with Stage II-IIIA non-small cell lung cancer (NSCLC) whose tumors express PD-L1=1%, as determined by FDA-approved test. This approval was based on results from an interim analysis of Phase III IMpower010 study. Roche has an extensive development program for Tecentriq including studies evaluating it alone and in combination with other medicines as well as studies in adjuvant settings across various types of tumors.
Tecentriq has previously shown clinically proven benefits in various types of lung cancer. It was also first approved cancer immunotherapy for front-line treatment of adults with small cell lung cancer in combination with carboplatin and chemotherapy. Tecentriq has also four approved indications in advanced NSCLC as single agent or in combination with targeted therapies and chemotherapies.
Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development said, “Tecentriq is now the first and only cancer immunotherapy available for adjuvant treatment of NSCLC, introducing a new era where people diagnosed with early lung cancer may have the opportunity to receive immunotherapy to increase their chances for cure.” “Today’s landmark approval gives physicians and patients a new way to treat early lung cancer that has the potential to significantly reduce risk of cancer recurrence, after more than a decade with limited treatment advances in this setting,” he added.
The results showed Tecentriq treatment, following surgery and platinum-based chemotherapy, reducing the risk of disease recurrence or death by 34% whose tumors expresses PD-L1≥1%, compared with best supportive care (BSC). Many patients with early-stage lung cancer experience disease recurrence following surgery. With availability of immunotherapy with surgery and chemotherapy, it offers patients new powerful tool to reduce the risk of relapse of lung cancer. This approval is important to screen lung cancer early and test for PD-L1 at diagnosis to help patients.
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