Next year, the company will submit regulatory filings for the drug in two molecularly defined indications and a next-generation sequencing companion diagnostic.
The changes include recommendations for first line immunotherapy in patients with high PD-L1 expression, and clarification on use of targeted therapies.
The so-called universal CDx approved by the FDA can gauge alterations across multiple genes associated with response to three lung cancer treatments.
Data from the meeting suggest that lung cancer patients with ALK-positive tumors may soon have two first-line options and more choices when their disease progresses.
Genentech's Alecensa and AstraZeneca's Tegrisso are the latest precision lung cancer drugs, and Xalkori might soon be an option for a new molecular subpopulation.
The preliminary results showed that 76 percent of study subjects under 40 had druggable mutations.
In developing the recommendations, the expert panel attempted to keep up with the fast-moving advances in oncology.
Entrectinib is Ignyta's lead product that the biotech is investigating in patients with tumors characterized by TrkA, TrkB, TrkC, ROS1, and ALK markers.
This article has been updated to correct the name of the Phase I extension trial to Study 1001. Originally published June 3.
The Jackson Laboratory has filed a complaint accusing Nanjing University of breeding and re-selling its mouse models, the Hartford Courant reports.
Oxford researchers are turning to virtual reality to visualize genes and regulatory elements, Phys.org says.
In Science this week: neutrophils rely on microRNA to protect against lung inflammation, and more.
China is moving forward with plans to sequence a million citizens, the Wall Street Journal reports.