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

• Dabrafenib and trametidnib (Tafinlar and Mekinist) received FDA approval for use in combination for patients with metastatic non-small cell lung cancer (NSCLC) with BRAFV600E mutation as detected by an […] Read more

• Pembrolizumab (Keytruda) received FDA approval for use in combination with pemetrexed and carboplatin for the first-line treatment of patients with metastatic nonsquamous NSCLC, irrespective of PD-L1 expression. This approval […] Read more

• The global, randomized phase III ALEX study was announced to have met its primary endpoint, demonstrating that alectinib (Alecensa), as an initial (first-line) treatment, significantly reduced the risk of […] Read more

Alectinib (Alecensa) received a positive opinion from the European Medicines Agency (EMA) for Medicinal Products for Human Use (CHMP) for the treatment of adult patients with advanced anaplastic lymphoma kinase […] Read more