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20-10-2021 | FDA | News

approvalsWatch

Adjuvant atezolizumab approved by FDA for NSCLC patients

Author: Hannah Kitt

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medwireNews: The US FDA has approved the use of adjuvant atezolizumab among patients with stage II–IIIA non-small-cell lung cancer (NSCLC) and a tumoral PD-L1 expression of 1% or more who have undergone resection and received platinum-based chemotherapy.

Suitable patients are to be identified using the companion VENTANA PD-L1 (SP263) diagnostic assay (Ventana Medical Systems, Inc, Oro Valley, Arizona, USA), simultaneously approved by the FDA.

The announcement is based on the phase 3 IMpower010 trial, in which patients given adjuvant atezolizumab had significantly better disease-free survival than those who received best supportive care.

The recommended adjuvant dose of atezolizumab is 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks for a maximum of 1 year.

medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2021 Springer Healthcare Ltd, part of the Springer Nature Group

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