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23-02-2018 | FDA | Drug approval | News

approvalsWatch

Durvalumab available for US stage III NSCLC patients

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medwireNews: Patients with unresectable stage III non-small-cell lung cancer (NSCLC) that has not progressed after concomitant platinum-based chemotherapy and radiotherapy can be treated with durvalumab, as per a US FDA decision.

Treatment with the anti-PD-L1 antibody led to a significant improvement in progression-free survival (PFS) relative to placebo in the phase III PACIFIC trial, such that the risk for progression was 48% lower with durvalumab. The median PFS times were 16.8 and 5.6 months, respectively.

The overall survival results were immature at the time of the interim analysis on which the FDA based its decision.

The recommended dose for durvalumab is 10 mg/kg, to be given intravenously over a 60-minute period every 2 weeks.

By Shreeya Nanda

medwireNews is an independent medical news service provided by Springer Healthcare. © 2018 Springer Healthcare part of the Springer Nature group

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