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FDA OKs Upfront Pembro for Advanced HER2+ Gastric Cancer medscape.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from medscape.com Daily Mail and Mail on Sunday newspapers.
On December 18, 2020, the Food and Drug Administration approved osimertinib (TAGRISSO, AstraZeneca Pharmaceuticals LP) for adjuvant therapy after tumor resection in patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. Efficacy was demonstrated in a randomized, double-blind, placebo-controlled trial (ADAURA, NCT02511106) in patients with EGFR exon 19 deletions or exon 21 L858R mutation-positive NSCLC who had complete tumor resection, with or without prior adjuvant chemotherapy. Eligible patients with resectable tumors (stage IB – IIIA) were required to have predominantly non-squamous histology and EGFR exon 19 deletions or exon 21 L858R mutations identified prospectively from tumor tissue in a central laboratory by the cobas® EGFR Mutation Test. A total of 682 patients were randomized (1:1) to receive osimertinib 80 mg orally once daily or ....