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Home Industry News & Regulatory Approvals

US FDA Approves Frontline Amivantamab Combination for Patients with EGFR exon 20 Insertion-mutated NSCLC

Erin Jungmeyer
on: March 12, 2024In: Industry News & Regulatory Approvals
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. Read more


US Approves Osimertinib with Chemotherapy for EGFR+ NSCLC; Approvals Pending in Other Countries

Erin Jungmeyer
on: February 27, 2024In: Industry News & Regulatory Approvals
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. Read more

Regulatory Approval Brings New Targeted Treatment Option for NSCLC to European Union

Erin Jungmeyer
on: February 13, 2024In: Industry News & Regulatory Approvals
Regulatory Approval Brings New Targeted Treatment Option for NSCLC to European Union

The European Commission recently approved adagrasib for KRAS G12C+ non-small cell lung cancer. Additionally, the US FDA has accepted a premarket approval application for tumor treating fields therapy. Read more

In Brief for November 8, 2023

Erin Jungmeyer
on: November 07, 2023In: Industry News & Regulatory Approvals
In Brief for November 8, 2023

October saw two approvals from the US FDA as well as caution from the agency’s Oncologic Drug Advisory Committee regarding the interpretation of CodeBreak 200 data; Takeda announces withdrawal of mobocertinib. Read more

In Brief for June 28, 2023

Erin Jungmeyer
on: June 27, 2023In: Industry News & Regulatory Approvals
In Brief for June 28, 2023

Canada to require health warnings on cigarettes. US FDA approves application for pemetrexed injection, grants priority review for repotrectinib. Read more

In Brief for May 24, 2023

Erin Jungmeyer
on: May 24, 2023In: Industry News & Regulatory Approvals, Meeting News
In Brief for May 24, 2023

Health Canada gives greenlight to cemiplimab-chemo combo for first-line treatment of advanced NSCLC. Early registration for WCLC 23 ends June 9. Read more

In Brief for April 26, 2023

Erin Jungmeyer
on: April 26, 2023In: Industry News & Regulatory Approvals
In Brief for April 26, 2023

US Food and Drug Administration grants Fast Track designation for novel mesothelioma therapy. Read more

Pragmatic Approach to Trial Design Born from Lung-MAP Substudy

Erin Jungmeyer
on: March 21, 2023In: Evolving Standards of Care, Industry News & Regulatory Approvals
Pragmatic Approach to Trial Design Born from Lung-MAP Substudy

In a recent interview with ILCN, the US FDA’s Dr. Harpreet Singh discusses the confirmatory Pragmatica-Lung trial and how the agency’s new pragmatic approach to trial design can streamline research and ultimately benefit patients. Read more

Narrow Focus Allows Pragmatica-Lung Trial to Minimize Eligibility Criteria, Significantly Reduce Data Collection, Researcher Says

Erin Jungmeyer
on: March 07, 2023In: Evolving Standards of Care, Industry News & Regulatory Approvals
Narrow Focus Allows Pragmatica-Lung Trial to Minimize Eligibility Criteria, Significantly Reduce Data Collection, Researcher Says

In a recent interview with ILCN, Dr. Karen Reckamp discussed the overall survival implications from the phase II Lung-MAP study and how the phase III follow-up Pragmatica-Lung trial aims to confirm that specific endpoint. Read more

In Brief for Feb. 8, 2023

John Austin
on: February 07, 2023In: Industry News & Regulatory Approvals, Names & News
In Brief for Feb. 8, 2023

Dr. Carolyn Dresler Joins Action on Smoking and Health (ASH) Board of Trustees; Novel Liquid Biopsy Assay for Lung Carcinoma Detection Receives FDA Breakthrough Device Designation. Read more

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