Federal Drug Administration (FDA) accepts new application for Entrectinib
On February 18th, the FDA accepted Genentech’s New Drug Application and granted Priority Review for the drug entrectinib for the treatment of adult and pediatric patients with NTRK fusion-positive, locally advanced or metastatic solid tumors who have either progressed following prior therapies or as initial therapy when there are no acceptable standard therapies and for metastatic, ROS1-positive non-small cell lung cancer (NSCLC).
The clinical trials that lead to this review include the Phase II STARTK-2, Phase 1 STARTRK-1, Phase 1 ALKA-372-001, and the Phase 1/b STARTRK-NG. You can read more about these trials in our blog covering the 2018 European Society for Medical Oncology (ESMO) conference.
According to the press release, “the FDA grants Priority Review to medicines determined to have the potential to provide significant improvements in the treatment, prevention, or diagnosis of a serious disease.“
While this is an exciting announcement, it’s important to remember that prior research suggests only 1 percent of all cancer patients present with TRK, therefore making this a small subset of the colorectal cancer population that will benefit from entrectinib.
A decision is expected to be made by August 2019. Be sure to follow @FightCRC on Facebook and Twitter for updates on the latest in colon and rectal cancer research.
For additional information on the NTRK fusion and additional biomarkers, head over to Fight CRC’s Biomarked resources.