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Alectinib Approved for Adjuvant Treatment for ALK-Positive Non–Small Cell Lung Cancer

The FDA has granted approval to alectinib (Alecensa®, Genentech, Inc.) for adjuvant treatment following tumor resection in patients with anaplastic lymphoma kinase (ALK)–positive non–small cell lung cancer (NSCLC), as detected by an FDA-approved test.   Why it matters: "ALK fusions represent 4% to 5% of patients with NSCLC. While we have several oral agents—tyrosine kinase inhibitors—approved for this driver alteration in the metastatic setting, use in the early-stage or adjuvant setting ha...

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Amivantamab-vmjw Approved for EGFR Exon 20 Insertion–Mutated Non–Small Cell Lung Cancer

The FDA has granted approval to amivantamab-vmjw (Rybrevant®, Janssen Biotech, Inc.) with carboplatin and pemetrexed for the first-line treatment of locally advanced or metastatic non–small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test.   In addition, the FDA granted traditional approval to amivantamab-vmjw for adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutation...

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Osimertinib Plus Platinum-Based Chemotherapy Approved for Locally Advanced or Metastatic Non–Small Cell Lung Cancer

The FDA has granted approval to osimertinib (Tagrisso®, AstraZeneca Pharmaceuticals LP) with platinum-based chemotherapy for patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.   Why it matters: "Osimertinib is a third-generation epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) that is selective for EGFR...

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Tepotinib Granted Traditional Approval for Metastatic Non–Small Cell Lung Cancer

The FDA has granted traditional approval to tepotinib (Tepmetko®, EMD Serono, Inc.) for adult patients with metastatic non–small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations. Tepotinib was previously granted accelerated approval for this indication on February 3, 2021.   Why it matters: "MET inhibitors have recently demonstrated clinical activity in patients with MET exon 14–skipping NSCLC; however, data with longer follow-up and in...

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Finding Real-World Response End Points in NSCLC Data Sets With Janet Espirito, PharmD

At the recent American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Janet Espirito, PharmD, a Senior Medical Director at Ontada, sat down with Oncology Data Advisor to discuss her presentation on identifying real-world end points for assessing response in patients receiving novel therapies for metastatic non–small cell lung cancer (NSCLC) outside of clinical trials.  

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Additional Advances in Non–Small Cell Lung Cancer Research and Clinical Trials With Ticiana Leal, MD

Last year, Dr. Ticiana Leal, Director of the Thoracic Medical Oncology Program at Winship Cancer Institute of Emory University, recorded a continuing medical education (CME)/nursing continuing professional development (NCPD)–accredited activity titled Harnessing Immunotherapy-Based Strategies for Advanced Non–Small Cell Lung Cancer (NSCLC). With numerous developments in the field occurring since recording the activity, including new FDA approvals and clinical trial results, Dr. Leal sat down with Oncology Data Advisor to provide an update on the rapidly evolving field of NSCLC immunotherapy.  

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Additional Advances in Non–Small Cell Lung Cancer Research and Clinical Trials With Ticiana Leal, MD

Last year, Dr. Ticiana Leal, Director of the Thoracic Medical Oncology Program at Winship Cancer Institute of Emory University, recorded a continuing medical education (CME)/nursing continuing professional development (NCPD)–accredited activity titled Harnessing Immunotherapy-Based Strategies for Advanced Non–Small Cell Lung Cancer (NSCLC). With numerous developments in the field occurring since recording the activity, including new FDA approvals and clinical trial results, Dr. Leal sat down wit...

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Additional Advances in Non–Small Cell Lung Cancer Research and Clinical Trials With Beth Sandy, MSN, CRNP

Oncology Data Advisor™ · Additional Advances in Non–Small Cell Lung Cancer Research and Clinical Trials Just under a year ago, Beth Sandy, a Thoracic Oncology Nurse Practitioner, co-led a continuing medical education (CME)/nursing continuing professional development (NCPD)–approved activity, Harnessing Immunotherapy-Based Strategies For Advanced Non–Small Cell Lung Cancer (NSCLC). In this interview, she provides an update on advancements made in treatment and supportive care s...

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Additional Advances in Non–Small Cell Lung Cancer Research and Clinical Trials With Beth Sandy, MSN, CRNP

Just under a year ago, Beth Sandy, a Thoracic Oncology Nurse Practitioner, co-led a continuing medical education (CME)/nursing continuing professional development (NCPD)–approved activity, Harnessing Immunotherapy-Based Strategies For Advanced Non–Small Cell Lung Cancer (NSCLC). In this interview, she provides an update on advancements made in treatment and supportive care strategies since recording. Oncology Data Advisor: Welcome to Oncology Data Advisor, a digital resource for the multidiscipl...

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Pembrolizumab Approved for Neoadjuvant/Adjuvant Treatment of Non–Small Cell Lung Cancer

The FDA has approved pembrolizumab (Keytruda®, Merck) for non–small cell lung cancer (NSCLC) as neoadjuvant treatment in combination with platinum-containing chemotherapy, and with continuation of single-agent pembrolizumab as post-surgical adjuvant treatment for resectable tumors, defined as those with a tumor ≥4 cm or node-positive.   Why it matters: "In patients with NSCLC, pembrolizumab has shown efficacy as monotherapy in the adjuvant and advanced settings and in combination with chemo...

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Pralsetinib Approved for Non–Small Cell Lung Cancer With RET Gene Fusions

The FDA has granted regular approval to pralsetinib (Gavreto®, Genentech, Inc.) for adult patients with metastatic rearranged during transfection (RET) fusion–positive non–small cell lung cancer (NSCLC) as detected by an FDA-approved test. Previously, pralsetinib was granted accelerated approval for the NSCLC indication on September 4, 2020, based on the initial overall response rate and duration of response findings in 114 patients. Based on data of the addition of 123 patients and 25 months of...

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Assessing Proficiency in Squamous Non–Small Cell Lung Cancer Management

i3 Health recently provided an online continuing medical education (CME)/nursing continuing professional development (NCPD)–accredited activity that has challenged the health care team's proficiency in managing metastatic squamous non–small cell lung cancer (NSCLC). Lung cancer is the second most common cancer in the United States between both men and women, with the American Cancer Society estimating a total of 238,340 new cases being diagnosed and 127,070 deaths occurring throughout 2023. Appr...

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Pembrolizumab Approved for Adjuvant Treatment of Non–Small Cell Lung Cancer

The FDA has approved pembrolizumab (Keytruda®, Merck) for adjuvant treatment of stage IB, II, or IIIA non–small cell lung cancer (NSCLC), following resection and platinum-based chemotherapy. "Although adjuvant chemotherapy improves overall survival in completely resected NSCLC, the absolute 5-year survival benefit is moderate compared with observation alone," wrote Mary O'Brien, MD, Head of Royal Marsden Hospital's Lung Unit, and colleagues, in their published results of the KEYNOTE-091 trial (N...

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Adagrasib Approved for KRAS G12C–Mutated Non–Small Cell Lung Cancer

The FDA has granted accelerated approval to adagrasib (Krazati™, Mirati Therapeutics, Inc.) for treatment of adult patients with kirsten rat sarcoma viral oncogene homologue (KRAS) G12C–mutated locally advanced or metastatic non­–small cell lung cancer (NSCLC). Patients should have received one prior line of systemic therapy. Adagrasib is a rat sarcoma virus (RAS) guanosine triphosphatase (GTPase) family inhibitor. "Adagrasib (MRTX849), a potent, orally available, small molecule covalent inhibit...

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Tremelimumab Plus Durvalumab and Platinum-Based Chemotherapy Approved for Metastatic NSCLC

The FDA has approved tremelimumab (Imjudo®, AstraZeneca) in combination with durvalumab (Imfinzi®, AstraZeneca) and platinum-based chemotherapy for patients with metastatic non–small cell lung cancer (NSCLC) who have no sensitizing epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. Tremelimumab is a fully human immune checkpoint inhibitor against CTLA-4. "Although some patient subsets, such as those with higher levels of tumor programm...

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Cemiplimab-rwlc Approved for Treatment of Non–Small Cell Lung Cancer

The FDA has granted approval of cemiplimab-rwlc (Libtayo®, Regeneron Pharmaceuticals, Inc.) in combination with platinum-based chemotherapy for treatment of advanced non–small cell lung cancer (aNSCLC) with no epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or ROS proto-oncogene 1 (ROS1) aberrations, and no prior systemic treatment. Cemiplimab-rwlc is a fully human immune checkpoint inhibitor targeting the programmed cell death receptor-1 (PD-1). "Pembrolizumab and ate...

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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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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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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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Supporting Educational Needs in Treatment of Advanced Non–Small Cell Lung Cancer

An educational enduring activity provided by i3 Health demonstrated significant learning outcomes in the selection of treatment for patients with anaplastic lymphoma kinase (ALK)–positive advanced non–small cell lung cancer (NSCLC). This activity was created to advise clinicians on the development of individualized treatment plans based on the best available evidence and emerging guideline recommendations. Lung cancer is the second most common cancer in the United States, and the first most dead...

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