Astellas Files Personalized Tarceva In First-line Lung Cancer With FDA
This article was originally published in Pharmaceutical Approvals Monthly
If successful, filing in EGFR-positive patients could give Roche/Astellas’ Tarceva a commercial boost, broadening erlotinib’s role in non-small-cell lung cancer.
You may also be interested in...
FDA accepts the NDA for afatinib – among Boehringer’s first cancer drugs – for review in first-line EGFR-mutation positive non-small cell lung cancer. Filing is supported by LUX-Lung 3 study, in which the drug showed a 4.2 month progression-free survival benefit over what some describe as the most effective chemo doublet available.
FDA has set a high bar for maintenance indications, which allow longer term use. With overall survival data, Eli Lilly’s Alimta (pemetrexed) has met that hurdle and is now approved for longer use in first-line nonsquamous non-small cell lung cancer.
Biomarker-guided targeted therapy has become a standard approach to oncology R&D, but few new targeted drugs have reached the market for lung cancer. A new wave of research could change that, and improve the outlook for lung cancer treatment.