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EU Approval Sought for Frontline Lazertinib Plus Amivantamab in EGFR+ NSCLC

A marketing authorization application seeking the approval of the combination of lazertinib and amivantamab in the first-line treatment of adult patients with advanced non­–small cell lung cancer harboring EGFR mutations has been submitted to the European Medicines Agency.
Catherine Taylor European Medicines Agency Janssen Pharmaceutical Companies Of Johnson European Mediciens Agency European Medicines Therapy Area Strategy

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Lenvatinib Plus Pembrolizumab Fails to Improve OS and PFS Over Docetaxel in Stage IV NSCLC

Lenvatinib plus pembrolizumab did not provide a survival advantage vs standard-of-care docetaxel in patients with advanced-stage non–small cell lung cancer who experienced disease progression following prior exposure to a PD-L1 inhibitor and platinum-based chemotherapy.
Natashab Leighl Oncology Congress Princess Margaret Cancer Centre Phase 3 Leap 008 Trial Nct03976375 2023 Esmo Immuno Oncology Congress

EMA Validates MAA for Repotrectinib in ROS1+ NSCLC and NTRK+ Solid Tumors

The European Medicines Agency has validated its marketing authorization application for repotrectinib in adult patients with ROS1 TKI-naive or -pretreated locally advanced or metastatic non–small cell lung cancer harboring ROS1 fusions, as well as adult and pediatric patients with TKI-naive and pretreated NTRK-positive locally advanced or metastatic solid tumors.
United States Repotrectinib Augtyro Joseph Fiore European Medicines Agency Drug Administration Point Therapeutics Inc

Vibostolimab Plus Pembrolizumab Coformulation ± Docetaxel Did Not Significantly Improve PFS in NSCLC

A coformulation of vibostolimab and pembrolizumab with or without docetaxel failed to result in a statistically significant improvement in progression-free survival compared with docetaxel alone in patients with metastatic non­–small cell lung cancer.
Scot Ebbinghaus Oncology Annual Congress Merck Research Laboratories Non Small Cell Lung Cancer

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