Regulators in the country granted additional approval of the test as a companion diagnostic for Rozlytrek, marketed in Japan by Roche's Chugai Pharmaceutical.
Researchers are collecting genomic and clinical data on cancer patients outside of clinical trials to understand tumor biology, treatment efficacy, and care gaps.
In the Phase I/IB study, only patients with NTRK or ROS1 fusions, or an ALK fusion or mutation responded to entrectinib, while patients without these tumor markers didn’t respond.
In the JAMA study, researchers confirmed the previously known clinical and genomic features of NSCLC patients in their large clinico-genomics database.
The draft guidelines have intrigued industry players interested in pursuing labeling that would allow their CDx to direct treatment for a class of drugs instead of one drug.
Next year, the company will submit regulatory filings for the drug in two molecularly defined indications and a next-generation sequencing companion diagnostic.
