Selpercatinib Approved for RET Fusion-Positive Non-Small Cell Lung Cancer

The FDA has granted regular approval selpercatinib (Retevmo®, Eli Lilly and Company) for treatment of adult patients with locally advanced or metastatic rearranged during transfection (RET) gene fusion non-small cell lung cancer (NSCLC). Selpercatinib previously received an accelerated approval from the FDA based on its initial trial results in May 2020. This comes in combination with an FDA approval of the Oncomine Dx Target (ODxT) Test (Thermo Fisher Scientific) as a companion diagnostic for s...

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Trastuzumab Deruxtecan First Approval for HER2-Mutant Non–Small Cell Lung Cancer

The FDA has granted accelerated approval to fam-trastuzumab deruxtecan-nxki (T-DXd) (Enhertu®, Daiichi Sankyo Inc.) for treatment of adult patients with unresectable or metastatic non–small cell lung cancer (NSCLC) with human epidermal growth factor receptor 2 (HER2) mutations. This approval is specific to individuals who have undergone previous systemic therapy. Trastuzumab deruxtecan is the first drug to be approved for treatment of HER2-mutant NSCLC. "HER2 mutations are an established molecul...

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Capmatinib Granted Regular Approval for Metastatic Non–Small Cell Lung Cancer

The FDA has granted regular approval to capmatinib (Tabrecta®, Novartis Pharmaceuticals Corp.) for treatment of adult patients with metastatic non–small cell lung cancer (NSCLC) who have tumors evolving into the mesenchymal-epithelial transition exon 14 skipping (METex14) mutation. Capmatinib was previously granted accelerated approval in May 2020 based on initial data from the GEOMETRY mono-1 trial (NCT02414139); due to updated results, the FDA is now converting it to regular approval. "Activat...

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Advancing Treatment for Non–Small Cell Lung Cancer: Exploring the Results of Adagrasib With Alexander Spira, MD, PhD, FACP

At the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Alexander Spira, MD, PhD, FACP, Director of the Thoracic and Phase I Program at the Virginia Cancer Specialists, the US Oncology Network, met with Oncology Data Advisor to discuss his presentation about adagrasib for KRAS G12–mutated non–small cell lung cancer with active central nervous system (CNS) metastases.  

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Dissolving Knowledge Gaps Regarding EGFR Exon 20 Insertion–Mutant NSCLC

An educational enduring activity and podcast provided by i3 Health has demonstrated knowledge gains and learning outcomes regarding new perspectives on diagnosis and treatment of epidermal growth factor receptor (EGFR) exon 20 insertion–mutant non–small cell lung cancer (NSCLC). Lung cancer is the second most common cancer in the United States, with 84% of lung cancers being classified as NSCLC. According to the American Cancer Society, in 2022 there are an estimated 236,740 new cases of lung ca...

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FDA Approves Nivolumab as Neoadjuvant Therapy for Resectable Non–Small Cell Lung Cancer

 The FDA has approved nivolumab (Opdivo®, Bristol-Myers Squibb) in combination with platinum doublet chemotherapy for the treatment of adult patients with early-stage, resectable non–small cell lung cancer (NSCLC). Nivolumab is a fully human programmed cell death ligand 1 (PD-L1)–targeted antibody, and its use is approved without regard for PD-L1 expression level. "In patients with nonmetastatic NSCLC, surgery has curative potential, but 30% to 80% who undergo resection experience recurrenc...

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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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New Opportunities in Advanced KRAS Mutation–Positive NSCLC With D. Ross Camidge, MD, PhD, and Beth Sandy, MSN, CRNP, OCN®

An estimated 228,820 new cases of lung cancer are reported in the United States annually, and 135,720 people die of the disease (ACS, 2020). Approximately 84% of cases are classified as non-small cell. Most patients are diagnosed at a locally advanced or metastatic stage, making systemic therapy the cornerstone of management (ACS, 2020). Although 70% of patients receiving first-line classical doublet chemotherapy demonstrate clinical benefit, most develop progressive disease within 5 months of t...

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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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Expert Guidance on the Treatment of ALK-Positive Advanced Non-Small Cell Lung Cancer With Mark G. Kris, MD and Nathan Pennell, MD

One of the two major subtypes of lung cancer, non-small cell lung cancer (NSCLC) is a challenging disease to treat, with most patients being diagnosed at a locally advanced or metastatic stage. Despite the use of tumor histology and relevant molecular biomarkers to determine treatment strategies, outcomes remain poor, with a 5-year survival rate of only 24%. In this episode of Oncology Data Advisor, Mark G. Kris, MD, William and Joy Ruane Chair in Thoracic Oncology at Memorial Sloan Kettering Ca...

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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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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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Atezolizumab for Previously Treated Non-Small Cell Lung Cancer: Julien Mazières, MD, PhD

For patients with previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC), effective treatment options with minimal toxicity remain limited. In this interview with i3 Health, Julien Mazières, MD, PhD, Professor of Respiratory Medicine at Toulouse University Hospital, discusses his collaborative research finding that atezolizumab increases long-term overall survival compared with docetaxel, regardless of histology, subsequent immunotherapy, and programmed death ligand...

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Cemiplimab for First-line Treatment of Advanced Non-Small Cell Lung Cancer: Ahmet Sezer, MD

Recently, the FDA granted approval to cemiplimab-rwlc (Libtayo®, Regeneron Pharmaceuticals, Inc.) for the first-line treatment of patients with advanced non-small lung cancer cell (NSCLC) whose tumors express programmed death ligand 1 (PD-L1) in at least 50% of their cells and whose tumors do not have aberrations in epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or C-ROS oncogene 1 (ROS1). In this interview, Ahmet Sezer, MD, Professor in the Department of Medical Onco...

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Roy Herbst, MD, PhD: Adjuvant Osimertinib for EGFR-Mutated Non-Small Cell Lung Cancer

Recently, the FDA approved osimertinib (Tagrisso®, AstraZeneca) as the first adjuvant therapy for patients with surgically resected early-stage non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations. In this interview, Roy Herbst, MD, PhD, Chief of Medical Oncology at Yale Cancer Center and lead investigator of the ADAURA trial, on which the approval was based, speaks with i3 Health about the significance of the approval of osimertinib for this patient populati...

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Lorlatinib Approved for Metastatic ALK-Positive Non-Small Cell Lung Cancer

The FDA has approved lorlatinib (Lorbrena®, Pfizer, Inc.) for the treatment of patients with anaplastic lymphoma kinase (ALK)–positive non-small cell lung cancer (NSCLC). A subset of NSCLCs defined by their chromosomal rearrangements of the ALK gene are highly sensitive to small-molecule ALK tyrosine kinase inhibitors (TKIs). Lorlatinib is a novel third-generation small-molecule ALK TKI that was designed to cross the blood-brain barrier in an effort to better treat patients whose disease has pro...

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Cemiplimab-rwlc Approved for Non-Small Cell Lung Cancer With High PD-L1 Expression

The FDA has approved cemiplimab-rwlc (Libtayo®, Regeneron Pharmaceuticals, Inc.), a programmed cell death protein 1 (PD-1) inhibitor, for the first-line treatment of patients with advanced non-small lung cancer cell (NSCLC) whose tumors express programmed death ligand 1 (PD-L1) in at least 50% of their cells and whose tumors do not have aberrations in epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or C-ROS oncogene 1 (ROS1). "An estimated 25% to 35% of advanced NSCLC ...

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Nab-Paclitaxel Noninferior to Docetaxel in Advanced Non-Small Cell Lung Cancer

In patients with previously treated advanced non-small cell lung cancer (NSCLC), nanoparticle albumin-bound (nab)–paclitaxel is noninferior to docetaxel, according to results of the phase 3 J-AXEL trial presented this past weekend at the International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer. Single-agent docetaxel is considered the second-line standard of care for patients with advanced NSCLC. However, recent studies have shown that nab-paclitaxel also de...

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Tepotinib Approved for Metastatic MET-Altered Non-Small Cell Lung Cancer

The FDA has granted accelerated approval to tepotinib (Tepmetko®, EMD Serono) for patients with metastatic non-small cell lung cancer (NSCLC) with mesenchymal-epithelial transition (MET) exon 14 skipping alterations. "A splice-site mutation that results in a loss of transcription of exon 14 in the oncogenic driver MET occurs in 3% to 4% of patients with NSCLC," wrote the investigators of the phase 2 VISION trial (NCT02864992) in their September publication in The New England Journal of Medicine,...

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