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Interim NADIM ADJUVANT Data Suggest Adjuvant Chemo-IO May Reduce Recurrence Risk in Patients Following Complete Resection
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Final FLAURA2 OS Data Show Osimertinib Plus Chemo Offers Benefit Compared with Monotherapy
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Potential Impact of GLP1-RAs on TKI-induced Weight Gain in Patients with NSCLC
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No “Known” Risk Factors: The Health Consequences of Radiation Therapy
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Discussion Covered Updates, Strategies, and Controversies in Lung Cancer Staging
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No PFS, OS Benefit Seen in Final Results from PACIFIC-2
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WCLC Attendees Hear Preview of Proposed Changes for the 9th Edition of the TNM Staging Classification for Thoracic Cancers
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Treatment of Immunotherapy-Related Dermatologic Toxicities: An Interview with Dr. Mario Lacouture
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A Holistic Approach to Patient Care
Industry News & Regulatory Approvals
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Osimertinib Approved as Adjuvant Therapy for NSCLC with Certain EGFR Mutations
December 18, 2020—The U.S. Food and Drug Administration (FDA) approved osimertinib as post-resection adjuvant therapy for patients with NSCLC and EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. ADAURA randomly assigned (1:1) 682 patients who had undergone surgery to 80 mg of oral osimertinib daily or to placebo…
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First Therapeutic Approval in 16 years for MPM
October 2, 2020—As part of the U.S. Food and Drug Administration’s (FDA) Project Orbis, the FDA approved combination nivolumab and ipilimumab for treatment-naive patients with unresectable malignant plueral mesothelioma (MPM). This is only the second FDA-approved systemic therapy for mesothelioma, and the first approval in 16 years. The approval was based on data from the…
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FDA Perspectives on the Use of Liquid Biopsy in NSCLC
The US Food and Drug Administration (FDA) recognizes the value of liquid biopsy in managing patients with cancer, and the agency is actively working to bring these assays to the clinic. Harpreet Singh, MD, Director of the Division of Oncology 2, shed light on past FDA efforts related to approval of liquid biopsy technologies as well as those currently underway. “Liquid biopsies for cancer require close interaction between the oncologist…
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Funding Opportunities for Innovative Multidisciplinary Cancer Research Teams
The US National Cancer Institute (NCI), a division of the US National institutes of Health (NIH), is partnering with Cancer Research UK, the world’s largest independent cancer research charity, to create Cancer Grand Challenges. The initiative aims to stimulate scientific creativity through highly competitive funding opportunities. Beginning in October 2020 and continuing through April 2021,…
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FDA Approves Pralsetinib for RET Fusion–Positive NSCLC
The US Food and Drug Administration (FDA) granted Accelerated Approval to pralsetinib as treatment for adults with metastatic NSCLC who harbor RET fusions. The first and only test to identify RET fusion–positive NSCLC, the Oncomine Dx Target Test, was granted premarket approval as a companion diagnostic for pralsetinib therapy. The test will be updated to report RET fusions by early 2021 in the United States. Pralsetinib’s approval…
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Huge Strides for Liquid Biopsy Assays with Two FDA Approvals
August 2020 was a groundbreaking month for liquid biopsy technology, with two assays approved by the US Food and Drug Administration (FDA) as companion diagnostics just weeks apart. The Guardant360 CDx assay, approved August 7, was the first liquid biopsy companion diagnostic to also incorporate next-eneration sequencing (NGS). Approved specifically to identify EGFR mutations in patients with NSCLC in order to appropriately select for osimertinib therapy, the assay …
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Dr. Harpreet Singh Discusses the Conduct of FDA Clinical Trials During the COVID-19 Pandemic
Harpreet Singh, MD, is director of Division of Oncology 2 at the U.S. Food and Drug Administration (FDA). In the following interview, she discusses the FDA’s response to the COVID-19 pandemic in how clinical trials are conducted, as well as the implications of these changes and what can be expected going forward. Q: How has…
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Oncology Trials Could Benefit From Increased Data on Tobacco Use
By Leah Lawrence Posted: June 24, 2020 As part of its declaration on tobacco cessation after cancer diagnosis, the IASLC recommended that smoking status, both initially and during the study, should be a required data element for all prospective clinical studies and that these studies should consider designs that could also determine the most effective…
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Changing E-Cigarette Technology Leads to Increased Complexity and Confusion—IASLC Statement Aims for Clarity
Posted: November 12, 2019 Dr. Matthew Steliga, chair of the IASLC Tobacco Control and Smoking Cessation Committee and thoracic surgeon and head of the Tobacco Cessation Program at Winthrop P. Rockefeller Cancer Institute, met with IASLC Lung Cancer News (ILCN) to discuss the impetus for the statement, the role of electronic cigarettes in tobacco cessation,…
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Breaking News Briefs
Nivolumab in the News The dosing schedule for nivolumab now includes a flat dose of 480 mg infused every 4 weeks (Q4W) for a majority of approved indications, including patients who received prior therapy for metastatic NSCLC. The U.S. Food and Drug Administration (FDA) approval provides an alternative to the previously available option of 240…