FDA Approves Atezolizumab for Non–Small Cell Lung Cancer

The FDA has granted approval to atezolizumab (Tecentriq®, Genentech) for the adjuvant treatment of patients with stage II to IIIA non–small cell lung cancer (NSCLC) whose tumors have a programmed death ligand 1 (PD-L1) expression on ≥1% of tumor cells. Atezolizumab is approved for use following resection and platinum-based chemotherapy in this patient population.The FDA has also approved the VENTANA PD-L1 (SP263) Assay (Ventana Medical Systems), a diagnostic device that will select patients with...
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FDA Approves Mobocertinib for EGFR Exon 20 Insertion–Mutated NSCLC

The FDA has approved mobocertinib (Exkivity™, Takeda) for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.In addition, the FDA has approved the OncomineTM Dx Target Test (Life Technologies Corporation) as a companion diagnostic device to determine eligibility for treatment with mobocertinib."EGFR exon 20 insertion mutations ...
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New Perspectives on Diagnosis and Treatment of EGFR Exon 20 Insertion–Mutant NSCLC With Helena Yu, MD, and Maria Arcila, MD

An estimated 235,760 new cases of lung cancer are reported in the United States annually, and 131,880 people die of the disease. Approximately 84% of cases are classified as non-small cell lung cancer (NSCLC) (ACS, 2021). The most frequent genomic aberration among patients with NSCLC is the epidermal growth factor receptor (EGFR) mutation, approximately 2%-10% of which are exon 20 insertion mutations (Kumari et al, 2019; Dersarkissian et al, 2019). Exon 20 insertion mutations are a heterogenous ...
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Amivantamab-vmjw Approved for EGFR Exon 20–Mutant Non-Small Cell Lung Cancer

The FDA has approved amivantamab-vmjw (Rybrevant®, Janssen) for patients with non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations. "Despite sharing similar tumor biology to other EGFR-mutant NSCLC tumors, no targeted therapies have been approved for NSCLC harboring EGFR exon 20 insertion mutations," wrote Joshua K. Sabari, MD, medical oncologist at NYU Medical Oncology Associates and colleagues, in the abstract presented in January at the W...
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Camrelizumab for Advanced Squamous Non-Small Cell Lung Carcinoma: Caicun Zhou, MD, PhD

Recently, the results of a phase 3 trial on camrelizumab were published in the Journal of Thoracic Oncology and presented at the European Lung Cancer Virtual Congress 2021. Camrelizumab was studied in the randomized, double-blind, multicenter trial as a treatment for advanced squamous non-small cell lung carcinoma (NSCLC). Patients with stages IIIB-IV squamous NSCLC were treated with carboplatin plus paclitaxel with camrelizumab or placebo in the first-line setting. Compared with those who recei...
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