FDA Approval Summary: Osimertinib for Adjuvant Treatment of Surgically Resected Non-Small Cell Lung Cancer, a Collaborative Project Orbis Review.

On December 18, 2020, the FDA approved osimertinib as adjuvant therapy in patients with non-small cell lung cancer (NSCLC) whose tumors have EGFR exon 19 deletions or exon 21 (L858R) mutations, as detected by an FDA-approved test. The approval was based on the ADAURA study, in which 682 patients with NSCLC were randomized to receive osimertinib ( = 339) or placebo ( = 343). Disease-free survival (DFS) in the overall population (stage IB-IIIA) was improved for patients who received osimertinib, with an HR of 0.

[The use of transvenous destruction of the atrioventricular junction for correcting hemodynamic disorders caused by ventricular-atrial conduction].

The authors studied disorders of central and intracardiac hemodynamics occurring in electrostimulation of the ventricles attended by retrograde stimulation of the cardia. The experiments were conducted on 8 anesthetized dogs in whom, after disclosure of intact ventriculoatrial conduction, transvenous destruction of the atrioventricular junction was performed. Clinical study was carried out in 12 patients with continuous electrostimulation of the ventricles which caused retrograde stimulation of the atria, and in 19 patients with supraventricular tachyarrhythmia who were subjected to transvenous endocardial destruction of the atrioventricular junction.