martedì, 27 luglio 2021
1 Dicembre 2017

Japanese Approval Sought for Frontline Osimertinib in NSCLC

November 27, 2017 – A supplemental new drug application (sNDA) has been submitted to Japan’s Pharmaceuticals and Medical Devices Agency for the use of osimertinib as a frontline treatment for patients with inoperable or recurrent EGFR-positive non–small cell lung cancer (NSCLC). AstraZeneca, the manufacturer of the third-generation, irreversible EGFR tyrosine kinase inhibitor (TKI), submitted the sNDA based on results from the phase III FLAURA … (leggi tutto)