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31-03-2017 | Non-small-cell lung cancer | News | Article

approvalsWatch

FDA approvals announced for PARP inhibitor, EGFR T790M-targeted agent

The poly ADP-ribose polymerase (PARP) inhibitor niraparib has been approved by the FDA as a maintenance therapy for adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who have achieved complete or partial tumor shrinkage with platinum-based chemotherapy.

“[Niraparib] offers patients a new treatment option that may help delay the future growth of these cancers, regardless of whether they have a specific genetic mutation,” explains Richard Pazdur, from the FDA Center for Drug Evaluation.

Niraparib was granted fast-track, priority review and breakthrough therapy status following trial results showing improved progression-free survival compared with placebo in patients with and without a germline BRCA mutation.

The PARP inhibitor also received an orphan drug designation with regard to its use in women with recurrent epithelial ovarian cancer.

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Osimertinib has been granted regular approval for use in carefully selected patients with metastatic non-small-cell lung cancer.

The oral agent should be given in a once daily dose of 80 mg in patients who have a positive result on an FDA-approved assay for the epidermal growth factor receptor T790M mutation and who developed disease progression on first-line tyrosine kinase inhibitor therapy.

The change in status from the original accelerated approval of osimertinib in 2015 follows results from the AURA3 trial showing an improvement in progression-free survival and overall response rate with the agent compared with chemotherapy.

By Lynda Williams

medwireNews is an independent medical news service provided by Springer Healthcare. © 2017 Springer Healthcare part of the Springer Nature group

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