Lorlatinib Approved for Metastatic ALK-Positive Non-Small Cell Lung Cancer

The FDA has approved lorlatinib (Lorbrena®, Pfizer, Inc.) for the treatment of patients with anaplastic lymphoma kinase (ALK)–positive non-small cell lung cancer (NSCLC). A subset of NSCLCs defined by their chromosomal rearrangements of the ALK gene are highly sensitive to small-molecule ALK tyrosine kinase inhibitors (TKIs). Lorlatinib is a novel third-generation small-molecule ALK TKI that was designed to cross the blood-brain barrier in an effort to better treat patients whose disease has pro...
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Cemiplimab-rwlc Approved for Non-Small Cell Lung Cancer With High PD-L1 Expression

The FDA has approved cemiplimab-rwlc (Libtayo®, Regeneron Pharmaceuticals, Inc.), a programmed cell death protein 1 (PD-1) inhibitor, for the first-line treatment of patients with advanced non-small lung cancer cell (NSCLC) whose tumors express programmed death ligand 1 (PD-L1) in at least 50% of their cells and whose tumors do not have aberrations in epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or C-ROS oncogene 1 (ROS1). "An estimated 25% to 35% of advanced NSCLC ...
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Nab-Paclitaxel Noninferior to Docetaxel in Advanced Non-Small Cell Lung Cancer

In patients with previously treated advanced non-small cell lung cancer (NSCLC), nanoparticle albumin-bound (nab)–paclitaxel is noninferior to docetaxel, according to results of the phase 3 J-AXEL trial presented this past weekend at the International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer. Single-agent docetaxel is considered the second-line standard of care for patients with advanced NSCLC. However, recent studies have shown that nab-paclitaxel also de...
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Tepotinib Approved for Metastatic MET-Altered Non-Small Cell Lung Cancer

The FDA has granted accelerated approval to tepotinib (Tepmetko®, EMD Serono) for patients with metastatic non-small cell lung cancer (NSCLC) with mesenchymal-epithelial transition (MET) exon 14 skipping alterations. "A splice-site mutation that results in a loss of transcription of exon 14 in the oncogenic driver MET occurs in 3% to 4% of patients with NSCLC," wrote the investigators of the phase 2 VISION trial (NCT02864992) in their September publication in The New England Journal of Medicine,...
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Adjuvant Icotinib Effective for EGFR-Mutated Non-Small Cell Lung Cancer

In patients with stage II–IIIA epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC), icotinib significantly improved disease-free survival in the adjuvant setting compared with standard chemotherapy, according to results of a phase 3 trial recently presented at the International Association for the Study of Lung Cancer (IASLC) 2020 World Conference on Lung Cancer. "Recent studies have shown significant benefits of EGFR tyrosine kinase inhibitors in the adjuvant sett...
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