The Lynx Group

Lung Cancer

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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On May 26, 2020, the FDA approved nivolumab (Opdivo; BMS) and ipilimumab (Yervoy; BMS) plus chemotherapy as first-line treatment of recurrent or metastatic squamous or nonsquamous non–small-cell lung cancer (NSCLC), regardless of PD-L1 expression, and with no EGFR or ALK aberrations. On May 15, the FDA approved nivolumab plus ipilimumab as first-line treatment of metastatic NSCLC with PD-L1 ≥1% expression.
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On May 18, 2020, the FDA approved a new indication for atezolizumab (Tecentriq; Genentech), a PD-L1 inhibitor, for the first-line treatment of adults with metastatic non–small-cell lung cancer (NSCLC) whose tumor has high PD-L1 expression (PD-L1 stained ≥50% of tumor cells or PD-L1 stained tumor-infiltrating immune cells covering ≥10% of the tumor area), and no EGFR or ALK genomic aberrations, as determined by an FDA-approved test.
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On May 15, 2020, the FDA approved a new indication for the first immunotherapy combination with the PD-1 inhibitor nivolumab (Opdivo; BMS) and the CTLA-4 inhibitor ipilimumab (Yervoy; BMS) as first-line treatment of adults with metastatic non–small-cell lung cancer (NSCLC) and PD-L1 expression of ≥1%, as determined by an FDA-approved test, but without EGFR or ALK genomic alterations.
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On March 27, 2020, the FDA approved a new indication for the PD-L1 inhibitor durvalumab (Imfinzi; Astra- Zeneca), in combination with etoposide and either carboplatin or cisplatin, as first-line treatment of patients with extensive-stage small-cell lung cancer (ES-SCLC). Imfinzi was previously approved by the FDA for the treatment of patients with metastatic urothelial cancer and for patients with unresectable, stage III non–small-cell lung cancer. The FDA granted durvalumab an orphan drug designation for this new indication.

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On January 29, 2020, Eli Lilly announced that the FDA granted priority review to their New Drug Application for selpercatinib (LOXO-292) for the treatment of patients with advanced RET fusion-positive non–small-cell lung cancer, RET-mutant medullary thyroid cancer, and RET fusion-positive thyroid cancer.
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Barcelona, Spain—The immunotherapy combination of nivolumab (Opdivo) plus ipilimumab (Yervoy) improved overall survival (OS) compared with chemotherapy as first-line treatment in patients with advanced non–small-cell lung cancer (NSCLC) and PD-L1 expression ≥1%, according to results of CheckMate 227.
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Barcelona, Spain—Osimertinib (Tagrisso), a third-generation EGFR tyrosine kinase inhibitor (TKI), extended overall survival (OS) compared with older TKI EGFR inhibitors, including gefitinib (Iressa) or erlotinib (Tarceva), as first-line treatment for patients with advanced non–small-cell lung cancer (NSCLC) and EGFR mutation in the phase 3 clinical trial called FLAURA.
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In This Article

  • Calquence Receives FDA Approval for the Treatment of Patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
  • Despite Some Positive Trends, Report Confirms Lung Cancer Remains the Deadliest Form of Cancer

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