NEW YORK – The UK's National Institute for Health Care Excellence (NICE) today published a final draft guidance recommending that the National Health Service make entrectinib (Roche's Rozlytrek) available as a treatment for patients with ROS1-positive, advanced non-small cell lung cancer (NSCLC) who have not received previous ROS1 inhibitors.
Entrectinib has already received approval from the US Food and Drug Administration for the same indication, as well as for patients with NTRK gene fusion-positive solid tumors. Several weeks ago, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) also issued a conditional marketing authorization for the agent in the EU.
According to NICE, the positive recommendation is based on data from three separate clinical trials that collectively demonstrated that entrectinib can shrink patients' tumors and allow them to live progression free for a median of 16.8 months, including patients whose cancer has spread to the brain. Additionally, based on the drug's demonstrated superiority over pemetrexed plus platinum chemotherapy, which is currently standard of care in this setting, NICE said it considers entrectinib a life-extending therapy for those who are without further options.
Patients with ROS1 mutations make up a small percentage of NSCLC; the mutation is found in fewer than 2 percent of patients with the disease. NICE estimated that, if approved by NHS, entrectinib would be available to roughly 412 patients in the UK. While it is important to note that this recommendation for entrectinib draws on pooled data from small, single-arm studies as opposed to a randomized clinical trial, NICE noted that these lung cancer patients — especially those who have brain metastases — do not currently have sufficient treatment options, and that entrectinib's cost-effectiveness falls within an acceptable range for end-of-life treatment.