The Lynx Group

Lung Cancer

On February 3, 2021, the FDA accelerated the approval of oral tepotinib (Tepmetko; EMD Serono) for adults with metastatic non–small-cell lung cancer (NSCLC) harboring MET exon 14 (METex14) skipping alterations. This approval is for treatment-naïve patients as well as for patients who have received previous therapy. Tepotinib is the first MET inhibitor approved by the FDA and should be selected for treatment based on the presence of METex14. The FDA has granted tepotinib breakthrough therapy and orphan drug designations.
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On December 18, 2020, the FDA approved osimertinib (Tagrisso; AstraZeneca) for adjuvant therapy after tumor resection in patients with non–small-cell lung cancer (NSCLC) and EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. The FDA approved this application 2 months ahead of the FDA goal date and granted it a breakthrough therapy designation. Osimertinib was previously approved for the first-line treatment of metastatic NSCLC and EGFR exon 19 deletions or exon 21 L858R mutations, and for the treatment of metastatic NSCLC and EGFR T790M mutation after EGFR tyrosine kinase inhibitor therapy.
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Lorlatinib (Lorbrena) significantly improved progression-free survival (PFS) and intracranial response rates compared with the former standard of care, crizotinib (Xalkori), as first-line treatment for patients with advanced ALK-positive non–small-cell lung cancer (NSCLC), as reported in a planned interim analysis of the CROWN trial.
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First-line treatment with the high-affinity, highly potent PD-1 inhibitor cemiplimab-rwlc (Libtayo) significantly improved overall survival (OS) and progression-free survival (PFS) compared with standard platinum-based chemotherapy in patients with advanced non–small-cell lung cancer (NSCLC) and PD ligand 1 (PD-L1) expression on at least 50% of tumor cells. The results of the second preplanned interim analysis of the phase 3 EMPOWER-Lung 1 clinical trial were presented at the 2020 virtual meeting of the European Society for Medical Oncology (ESMO).
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Capmatinib (Tabrecta), a selective inhibitor of the mesenchymal-epithelial transition (MET) receptor, showed significant antitumor activity in patients with metastatic non–small-cell lung cancer (NSCLC) and gene mutations that lead to MET exon 14 skipping, according to the results of a recently published study.
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Treatment with osimertinib (Tagrisso) in the adjuvant setting significantly improves disease-­free survival (DFS) in patients with localized non–small-cell lung cancer (NSCLC) with an EGFR mutation, according to results presented by Roy S. Herbst, MD, PhD, FACP, FASCO, Chief of Medical Oncology, Yale Cancer Center, New Haven, CT, at the ASCO 2020 virtual annual meeting.
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Updated results of the phase 3 CASPIAN clinical trial continue to show that durvalumab (Imfinzi) added to standard chemotherapy improves overall survival (OS) for patients with treatment-naïve extensive-stage small-cell lung cancer (ES-SCLC), according to a presentation at the ASCO 2020 virtual annual meeting.
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Capmatinib (Tabrecta), an oral kinase inhibitor, has shown clinical activity in patients with high-level MET-amplified advanced non–small-cell lung cancer (NSCLC), according to new data presented at the ASCO 2020 virtual annual meeting.
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On June 15, 2020, the FDA accelerated the approval of lurbinectedin (Zepzelca; Jazz Pharma/Pharma Mar), an intravenous alkylating drug, for the treatment of adults with metastatic small-cell lung cancer that has progressed during or after platinum-based chemotherapy. The FDA granted lurbinectedin an orphan drug designation for this indication.
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On May 29, 2020, the FDA approved ramucirumab (Cyramza; Eli Lilly) in combination with erlotinib (Tarceva) for first-line treatment of patients with metastatic non–small-cell lung cancer (NSCLC) and epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations. Ramucirumab was previously approved for several types of cancer, including, in combination with docetaxel, for metastatic NSCLC, after platinum-based chemotherapy.
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