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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

 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...

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...

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 ...