Industry News & Regulatory Approvals

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 […]

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 […]

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 […]

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 […]

• 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 […]

• 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 […]

• 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 […]

• 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 […]