Genentech, a member of the Roche Group has announced that the US Food and Drug Administration (FDA) has accepted the company’s New Drug Applications (NDAs) and granted Priority Review for entrectinib (RXDX-101).
The decision was made for the treatment of adult and paediatric patients with neurotrophic tropomyosin receptor kinase (NTRK) fusion-positive, locally advanced or metastatic solid tumours who have either progressed following prior therapies or as initial therapy when there are no acceptable standard therapies.
These NDAs are based on results from the integrated analysis of the pivotal Phase II STARTRK-2, Phase I STARTRK-1 and Phase I ALKA-372-001 trials, and data from the Phase I/Ib STARTRK-NG study, with the FDA expected to make a decision on approval by August 18, 2019.
The studies found that the treatment shrank tumours in 77.4% of people with locally advanced or metastatic ROS1-positive NSCLC. In addition, it demonstrated a durable response of more than two years and was shown to shrink intracranial tumours in more than half of people with central nervous system metastases at baseline.
“Entrectinib represents a unique approach to cancer treatment that can potentially target a range of hard-to-treat and rare NTRK fusion-positive tumours regardless of their site of origin, as well as treat ROS1-positive non-small cell lung cancer,” said Sandra Horning, chief medical officer and head of Global Product Development.
She continued, “By combining comprehensive genomic profiling with actionable targeted therapies, like entrectinib, we are advancing our personalised healthcare goal to find the right treatment for each patient. We are working closely with the FDA to make this potential new option available as soon as possible.”
The drug is currently being investigated across a range of solid tumour types, including breast, cholangiocarcinoma, colorectal, gynecological, neuroendocrine, non-small cell lung, salivary gland, pancreatic, sarcoma and thyroid cancers.