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.
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.
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