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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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US FDA Grants Accelerated Approval to Tarlatamab-dlle for Extensive-stage Small Cell Lung Cancer
The first-in-class immunotherapy offers a new option for SCLC patients with disease progression on or after platinum-based chemotherapy.
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European Commission OKs Tislelizumab for NSCLC
In other regulatory news, the US FDA recently granted a Breakthrough Therapy Designation for sunvozertinib for first-line treatment of advanced non-small cell lung cancer with EGFR Exon 20 Insertion mutations.
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ALINA Trial Leads to New Treatment Option for Early-Stage ALK+ NSCLC
The US approved alectinib as adjuvant treatment based on a significant DFS benefit compared to chemotherapy.
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Stark Contrast in Recent Tobacco Control Laws Worldwide
The UK recently moved to ban smoking for individuals born after 2009 while the US delayed implementation of a ban on menthol cigarettes—again.
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Regulatory News for April 24, 2024
US FDA grants accelerated approval of HER2-targeting antibody drug conjugate; China accepts supplemental new drug application for savolitinib.
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US Food and Drug Administration Accepts New Drug Application for Ensartinib
The filing was based on results from a global phase III study designed to compare the ALK inhibitor to crizotinib in the first-line treatment of ALK-positive NSCLC.
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Regulating Artificial Intelligence
The US FDA’s Dr. Harpreet Singh talks with ILCN about what the increasing use of AI means for the agency as it works to ensure drugs and devices are safe and effective.
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US FDA Grants Breakthrough Therapy Designation for Novel TKI Targeting HER2, EGFR
The move was supported by preliminary evidence from a phase I, first-in-human study in patients with advanced NSCLC.
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US FDA Approves Frontline Amivantamab Combination for Patients with EGFR exon 20 Insertion-mutated NSCLC
The agency also granted approval to amivantamab as a treatment for patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations who progressed on or after platinum-based chemotherapy.
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US Approves Osimertinib with Chemotherapy for EGFR+ NSCLC; Approvals Pending in Other Countries
Other recent regulatory moves include the FDA granting full approval to tepotinib for metastatic NSCLC harboring MET exon skipping alterations and new applications for amivantamab in the US and Europe.