Lung Cancer

Lurbinectedin Gains Orphan Drug Status for Small Cell Lung Cancer

By August 03, 2018

A Phase 2 multicenter trial examined the safety and efficacy of lurbinectedin in several types of advanced solid tumors, including SCLC.

Alimta Labeling Updated to Include Combo Treatment for NSCLC

By June 05, 2018

Merck initially gained accelerated approval for Keytruda with Alimta and carboplatin in May 2017.

Tagrisso Approved as First-Line Treatment for EGFR-Mutated NSCLC

By April 19, 2018

Results showed that progression-free survival (PFS), the primary endpoint, was significantly longer in Tagrisso-treated patients vs EGFR tyrosine kinase inhibitor-treated patients (18.9 months vs 10.2 months; hazard ratio [HR] 0.46, 95% CI: 0.37, 0.57; P <.0001).

FDA Approves Expanded Indication for Gilotrif in NSCLC

By January 16, 2018

To determine if a patient is eligible for Gilotrif, physicians must conduct biomarker testing to determine the type of EGFR mutation present.

Lung Cancer Screening: Risk-Based Versus USPSTF Criteria Compared

January 04, 2018

Risk targeting may improve screening efficiency, but gains attenuated in terms of QALYs, cost

Alecensa Approved as First-Line Tx in ALK-Positive Metastatic NSCLC

By November 06, 2017

The approval was based on the Phase 3 ALEX study which evaluated the safety and efficacy of Alecensa versus crizotinib in patients with ALK-positive NSCLC who had not received prior systemic therapy for metastatic disease and whose tumors were characterized as ALK-positive by the VENTANA ALK CDx Assay.

Ready-to-Dilute Pemetrexed Formulation Gets Tentative FDA Approval

By October 30, 2017

Formulation does not require reconstitution, reducing the potential for dosing errors

CHEST: New Lung Cancer Screening Guidelines

By October 26, 2017

The manuscript has been submitted to CHEST for publication and findings will be presented at the CHEST 2017 Annual Meeting.

Zykadia Approved for First-Line ALK-Positive Metastatic NSCLC

By May 30, 2017

The FDA approval was based on data from the Phase 3, open-label, randomized, multicenter, global ASCEND-4 trial.

Noninvasive Biomarker May ID Lung Cancer

February 28, 2017

Simple technique is based on cancer DNA and seems accurate for use after chest CT scan, researchers say

New Pemetrexed Formulation to Be Reviewed by FDA

By January 03, 2017

The NDA proposes the use of ready-to-dilute pemetrexed injection for the treatment of locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) and mesothelioma (in combination with cisplatin).

Xalkori Approved for ROS1-Positive Metastatic NSCLC

By March 11, 2016

The FDA has approved Xalkori (crizotinib capsules; Pfizer) for the treatment of metastatic non-small cell lung cancer (NSCLC) in patients whose tumors are ROS1-positive.

FDA Approves Tagrisso to Treat Non-Small Cell Lung Cancer

November 13, 2015

The US Food and Drug Administration (FDA) has approved Tagrisso (osimertinib; AstraZeneca) for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, who have progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy.