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 […] Read more
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 […] Read more
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, […] Read more
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. […] Read more
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 […] Read more
New Lung Cancer Screening Guidelines Will Save Lives Reaction was swift and positive last week to new draft guidelines from the U.S. Preventive Services Task Force lowering the requirements for […] Read more
Tumors with high TMB responded well to combination in large patient population. By now the results of the phase III CheckMate-227 study are known by most. The primary endpoint of […] Read more
The FoundationOne CDx (F1CDx) test received full U.S. Food and Drug Administration (FDA) approval. F1CDx is the first breakthrough-designated, next-generation sequencing–based in vitro diagnostic (IVD) test to detect genetic mutations […] Read more
• Alectinib (Alecensa) received full FDA approval for the first-line treatment of patients with ALK-positive metastatic non-small cell lung cancer (NSCLC) as determined by an FDA-approved test. The approval was […] Read more
• Alectinib received FDA priority review designation for first-line treatment of patients with ALK-positive, locally advanced or metastatic NSCLC. The supplemental new drug application included results from the phase III […] Read more