EGFR+ Lung Cancer

In a 17-0 vote, the FDA’s Oncologic Drugs Advisory Committee unanimously recommended the approval of ABP-215, a biosimilar for bevacizumab.

Martin Gutierrez, MD, director, drug discovery/phase I unit, medical oncologist, thoracic and gastrointestinal oncology, John Theurer Cancer Center, discusses results for durvalumab (Imfinzi) for the treatment of non-small cell lung cancer.

Matthew D. Hellmann, MD, medical oncologist, Memorial Sloan Kettering Cancer Center, discusses the CheckMate-032 study, which explored nivolumab (Opdivo) with or without ipilimumab (Yervoy) for patients with small cell lung cancer (SCLC).

A look back at all the FDA news that happened in the month of June, including in multiple myeloma, hematology, sarcoma, and lung cancer.

Solange Peters, MD, PhD, has been elected the president of the European Society for Medical Oncology (ESMO) for the 2020-2021 term.

Ceritinib has been approved by the European Union (EU)&nbsp;for the first-line treatment of patients with <em>ALK</em>-positive advanced non&shy;&ndash;small cell lung cancer.

A retrospective analysis suggests that treatment with a MET tyrosine kinase inhibitor can prolong survival in patients with advanced non&ndash;small cell lung cancer with a <em>MET</em>&nbsp;exon 14 mutation.

The combination of dabrafenib (Tafinlar) and trametinib (Mekinist) has been approved by the FDA for the treatment of patients with <em>BRAF</em> V600&ndash;positive advanced or metastatic non&ndash;small cell lung cancer (NSCLC).

Mark Awad, MD, PhD, medical oncologist, Dana-Farber Cancer Institute, discusses the impact of MET inhibitors on survival among patients with <em>MET</em> exon 14-mutant non&ndash;small cell lung cancer.

The risk of disease progression was reduced by more than 40% and there was an average 6.5-month improvement in response duration with the second-generation EGFR inhibitor dacomitinib&nbsp;compared with gefitinib as a first-line treatment for patients with advanced, <em>EGFR</em>-mutant non&ndash;small cell lung cancer.

Leena Gandhi, MD, PhD, director of the Thoracic Medical Oncology Program at NYU Langone School of Medicine, discusses first-line carboplatin and pemetrexed with or without pembrolizumab for advanced nonsquamous non&ndash;small cell lung cancer.

The antibody-drug conjugate sacituzumab govitecan was well-tolerated and produced a median duration of response of 6.0 months in previously treated patients with metastatic non&ndash;small cell lung cancer.

Alice T. Shaw, MD, PhD, director, thoracic oncology, Massachusetts General Hospital, discusses results of the phase III clinical trial comparing alectinib (Alecensa) versus crizotinib (Xalkori) in first-line treatment for ALK-positive, advanced non&ndash;small cell lung cancer.

Two oncologists&nbsp;offer rationale for both sides of the argument for/against the upfront use of newer tyrosine kinase inhibitors for patients with ALK-positive or EGFR-mutant NSCLC.

Second-generation ALK inhibitor alectinib (Alecensa) demonstrated a 15-month improvement in progression-free survival compared with crizotinib (Xalkori), the first-generation ALK inhibitor and standard of care, in patients with&nbsp;<em>ALK</em>-positive non&ndash;small cell lung cancer.

It&rsquo;s been a busy month at the FDA. Here&rsquo;s a look back at all the news in the oncology field to come out of the FDA during the month of May.

Updates to the NCCN guidelines for the management of advanced NSCLC stress the importance of multiplexed biomarker testing at diagnosis to aid in the selection of appropriate first-line and subsequent lines of therapy.

Treatment of EGFR Mutant Non-Small Cell Lung Cancer

Ceritinib (Zykadia) has been approved by the FDA for the treatment of patients with <em>ALK</em>-positive, metastatic non&ndash;small cell lung cancer.

NSCLC with Multiple Sites of Metastasis and No Driver Mutation