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01-10-2018 | FDA | News

approvalsWatch

Dacomitinib approved for metastatic NSCLC with EGFR activating mutations

medwireNews: Dacomitinib is now a first-line treatment option for US patients with metastatic non-small-cell lung cancer who have tested positive for an EGFR exon 19 deletion or an exon 21 L8R8R substitution.

The FDA has approved the use of the selective, irreversible tyrosine kinase inhibitor of EGFR for patients whose mutations are confirmed using an authorized screening test.

The announcement follows the ARCHER 1050 trial results, which demonstrated improved efficacy for dacomitinib compared with gefitinib in patients with treatment-naïve disease positive for either mutation.

The recommended dose is 45 mg once daily given with or without food.

By Lynda Williams

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

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