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Japanese Approval Sought for Frontline Osimertinib in NSCLC

Jason M. Broderick @jasoncology
Published: Monday, Nov 27, 2017

lung cancer
A supplemental new drug application (sNDA) has been submitted to Japan’s Pharmaceuticals and Medical Devices Agency for the use of osimertinib (Tagrisso) as a frontline treatment for patients with inoperable or recurrent EGFR-positive non–small cell lung cancer (NSCLC).

Overall, 33.7% of patients experienced a grade ≥3 AE in the osimertinib group compared with 44.8% for erlotinib and gefitinib. Patients in the osimertinib group were less like to discontinue treatment because of AEs (13.3% vs 18.1%).
Ramalingam S, Reungwetwattana T, Chewaskulyong B, et al. Osimertinib vs standard of care (SoC) EGFR-TKI as first-line therapy in patients (pts) with EGFRm advanced NSCLC: FLAURA. Presented at: 2017 ESMO Congress; Madrid, Spain; September 9-12, 2017. Abstract LBA2_PR.

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