NEW YORK -- The UK National Institute for Health and Care Excellence on Friday recommended that selpercatinib (Eli Lilly's Retevmo in the US/ Retsevmo in the UK) be available to certain advanced RET-positive thyroid cancer patients through the UK's Cancer Drugs Fund.
In a draft guidance, NICE specifically recommended that the RET inhibitor be available for advanced RET fusion-positive thyroid cancer patients requiring systemic therapy after prior treatment with sorafenib (Bayer's Nexavar) or lenvatinib (Eisai's Lenvima) as well as for advanced RET-mutant medullary thyroid cancer patients requiring systemic therapy after prior treatment with cabozantinib (Exelixis' Cabometyx) or vandetanib (Sanofi Genzyme's Caprelsa).
The recommendation is based on data from several separate analyses from the ongoing LIBRETTO-001 Phase I/II trial of advanced solid tumor patients whose cancers harbor different types of RET activations. Among one cohort of RET fusion-positive, previously treated medullary thyroid cancer patients, the objective response rate was 69 percent, and among another of patients with previously treated advanced RET fusion-positive thyroid cancer, the objective response rate was 79 percent and the median progression-free survival time was just over 20 months.
Although NICE acknowledged in a statement that the clinical trial evidence for selpercatinib is still "highly uncertain," the independent appraisal committee determined that the agent should be available to patients through the Cancer Drugs Fund while additional data are collected. If further results demonstrate an overall survival benefit with selpercatinib, NICE said, the agent would be considered cost effective. Data from the ongoing trial as well as NHS practice will help address lingering uncertainty about the drug, according to NICE.
The estimated cost of a 28-day cycle of selpercatinib is £8,736 ($11,843), but in the event that the agent is recommended for routine use in the UK, NICE said that there would be a commercial arrangement, for which it did not disclose additional details.
Last year, the US Food and Drug Administration granted accelerated approval to selpercatinib for RET-mutant advanced or metastatic medullary thyroid cancer requiring systemic therapy as well as for RET fusion-positive thyroid cancer that requires systemic therapy and has stopped responding to radioactive iodine therapy.