Just ahead of schedule the FDA has come through with a key approval for Genentech’s entrectinib — now headed to the market as Rozlytrek.
Regulators approved the drug for ROS1-positive, metastatic non-small cell lung cancer as well as adult and pediatric patients (12 years of age and older) with solid tumors that have a NTRK gene fusion.
Roche lined up this approval once it struck a deal to buy Ignyta for $1.7 billion back in late 2017, winning its first OK in Japan two months ago. A priority review designation set up an accelerated PDUFA date for this Sunday, which regulators had no trouble beating.
Ignyta and Loxo had both distinguished themselves by taking a tumor-agnostic approach to cancer drug development, focusing on a specific genetic