NEW YORK – The UK's National Institute for Health and Care Excellence last week recommended that the Cancer Drugs Fund make selpercatinib (Eli Lilly's Retevmo in the US/Retsevmo in the UK) available to patients with advanced RET fusion-positive non-small cell lung cancer.
NICE specifically recommended the drug for RET-positive advanced NSCLC patients who require systemic therapy and have previously received immunotherapy or platinum-based chemotherapy. The recommendation to make the therapy available through the CDF will provide these patients access through the National Health Service while the sponsor collects more clinical and cost-effectiveness data.
NICE based its recommendation on data from the Phase I/II LIBRETTO-001 trial of selpercatinib in advanced solid tumors with RET fusions. In that study, 329 patients with RET fusion-positive advanced NSCLC were enrolled, and in an initial analysis of 105 patients, the objective response rate was 63.8 percent and the median progression-free survival was 16.5 months.
NICE noted in its final draft guidance that this data from LIBRETTO-001 is immature because progression-free survival and overall survival was not evaluable in some patients. While early data suggest treatment with selpercatinib extends survival by about three months compared to standard care, NICE noted that this is "highly uncertain" because the trial has not been running long enough to confirm survival benefit.
The estimated cost of a 28-day cycle of selpercatinib is £8,736 ($11,611), and Lilly is providing the drug within the CDF at an undisclosed discounted price.
In October, NICE also recommended selpercatinib for patients with RET-altered advanced thyroid cancer through the CDF.