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The dark cloud of what the U.S. FDA called potential “systemic bias” rained on Amgen Inc.’s bid for full approval of Lumakras (sotorasib), a KRAS-G12C inhibitor that was granted accelerated approval in May 2021 for locally advanced or metastatic non-small-cell lung cancer after at least one systemic therapy.
Advisers to the US Food and Drug Administration on Thursday found that data from a late-stage trial of Amgen's Lumakras could not be relied on.
Expert oncologist Yasir Elamin, MD, shares data from the BRIGHTSTAR trial and considers how it may inform real-world use of brigatinib in patient with ALK-rearranged metastatic non–small cell lung cancer.
Expert oncologist Helena Yu, MD, reviews data from HERTHENA-Lung01 following the IASLC 2023 World Conference on Lung Cancer and considers how patritumab deruxtecan will fit into clinical practice.
Specialists evaluate their clinical strategies for managing second-line driver-negative and initial PD-L1 negative patients.