Industry News & Regulatory Approvals

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 low dose CT imaging as a screening tool for those at risk for lung cancer. Current recommendations call for low-dose CT scans for 55- to…

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 progression-free survival was met, and the immunotherapy (IO) combination of nivolumab and ipilimumab was proven superior to chemotherapy in the first line for patients with…

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 in 324 genes and two genomic signatures in any solid tumor type. Simultaneous to FDA approval, the Centers for Medicare & Medicaid Services (CMS) proposed…

• 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 based on results from the phase III ALEX study that compared alectinib to crizotinib. In addition, the FDA also converted alectinib’s initial accelerated approval in…

• 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 ALEX and J-ALEX studies, which were designed to evaluate alectinib as first-line treatment for patients with ALKpositive, locally advanced or metastatic NSCLC as detected by…

• 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 FDAapproved test. This is the first FDA approval specifically for treatment of patients with BRAFV600E mutationpositive metastatic NSCLC. (6/22/17) • The FDA also approved the…

• 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 was based on randomized phase II data from KEYNOTE-021, Cohort G1, in 123 previously untreated patients with metastatic nonsquamous NSCLC and no evidence of EGFR…

• 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 disease worsening or death (progression-free survival) compared to crizotinib in people with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). This is the…

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 (ALK)-positive non-small cell lung cancer (NSCLC) whose disease has progressed following treatment with crizotinib. Based on this positive CHMP recommendation, a final decision is expected…

RECENT APPROVALS: Pembrolizumab (Keytruda) was approved by the FDA for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1. The following indications for pembrolizumab were added for metastatic NSCLC: (1) tumors that have high PD-L1 expression (>50%), with no EGFR or ALK genomic tumor aberrations, and no prior systemic…