Lung Cancer

Opdivo plus Yervoy and Chemotherapy Approved as First-Line Therapy for Metastatic NSCLC, Regardless of PD-L1 Expression
FDA Approvals, News & Updates, Lung Cancer
Web Exclusives
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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Tecentriq Approved as First-Line Therapy for Metastatic NSCLC with High PD-L1 Expression
FDA Approvals, News & Updates, Lung Cancer
Web Exclusives
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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Opdivo-Yervoy First Immunotherapy Combo Approved for First-Line Therapy of Patients with Metastatic NSCLC
FDA Approvals, News & Updates, Lung Cancer
Web Exclusives
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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FDA Approves Imfinzi as First-Line Treatment, with Chemotherapy, for Extensive-Stage Small-Cell Lung Cancer
FDA Approvals, News & Updates, Lung Cancer
April 2020, Vol 11, No 2

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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FDA Grants Priority Review to New Drug Application for the RET Kinase Inhibitor Selpercatinib
By Yvette Florio Lane
FDA Approvals, News & Updates, In the News, Lung Cancer, Personalized Medicine, Thyroid Cancer
Web Exclusives
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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Nivolumab plus Ipilimumab Combination Improves Survival in Patients with Metastatic NSCLC
Lung Cancer, Personalized Medicine, Solid Tumors
December 2019, Vol 10, No 6
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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Osimertinib Superior TKI as First-Line Treatment of Advanced NSCLC with EGFR Mutation
By Phoebe Starr
Lung Cancer, Personalized Medicine, Solid Tumors
December 2019, Vol 10, No 6
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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November 25, 2019 – Oncology News & Updates
By Yvette Florio Lane
FDA Approvals, News & Updates, In the News, Leukemia, Lung Cancer, Lymphoma
Web Exclusives
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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
Long-Term Data Confirm Survival Benefit for Pembrolizumab in Advanced NSCLC
By Phoebe Starr
Lung Cancer, Solid Tumors, Personalized Medicine
October 2019, Vol 10, No 5
Chicago, IL—Treatment with the immune checkpoint inhibitor pembroliz­umab (Keytruda) dramatically improved 5-year survival for patients with advanced non–small-cell lung cancer (NSCLC) compared with expected survival in the preimmunotherapy era, according to the 5-year follow-up data from the phase 1b KEYNOTE-001 clinical trial. The study was presented at ASCO 2019 and was published simultaneously in the Journal of Clinical Oncology.
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