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12-04-2019 | Oncology | News | Article

approvalsWatch

KEYNOTE-042 leads to first-line pembrolizumab approval for stage III NSCLC

medwireNews: The US FDA has approved the use of pembrolizumab as a first-line therapy for patients with stage III non-small-cell lung cancer (NSCLC) that have a PD-L1 tumor proportion score (TPS) of at least 1%.

Pembrolizumab may now be given to patients who are not candidates for surgery or definitive chemoradiation and whose tumors do not have EGFR or ALK aberrations. The PD-L1 TPS must be determined using an FDA-approved assay.

The decision is based on findings from the KEYNOTE-042 trial which showed that single-agent pembrolizumab achieved significantly better overall survival than platinum-based chemotherapy in patients with treatment-naïve locally advanced or metastatic disease.

By Lynda Williams

medwireNews is an independent medical news service provided by Springer Healthcare. © 2019 Springer Healthcare part of the Springer Nature group

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