The new Cancer Drugs Fund (CDF) procedure, launched on 29 July, has omitted lenvatinib from approval for advanced thyroid cancer.

NICE has indicated it will not be able to issue final guidance on the treatment until around June 2018.

This follows verdicts from 2015, when it was refused entry to the CDF as it was closed to new medicines and was not scheduled for assessment by NICE due to its low budget impact.

Lenvatinib is indicated for the treatment of adults with progressive locally advanced or metastatic, differentiated (papillary, follicular, Hürthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine (RAI-R)[ii] and was granted an accelerated assessment and approved by the European Commission in May 2015.

It is available in many countries in Europe already, including Germany where it has been available from May 2015.

“As a clinician I am now in the difficult position of having to explain to my patients why I cannot prescribe a drug that is available in other European countries. This is obviously very disappointing given the significant progression free survival benefit demonstrated by lenvatinib for patients with radioiodine refractory DTC and my colleagues and I will not be able to do so in the immediate foreseeable future,” comments Dr Nick Reed, Consultant Clinical Oncologist, Beatson Oncology Centre, Glasgow, UK.

In a recent pivotal trial of lenvatinib, a median progression free survival benefit of 18.3 months versus 3.6 months for placebo (p<0.0001) was reported in radioiodine refractory differentiated thyroid cancer.

Nearly two-thirds of patients responded (ORR measure) to the treatment with a significant objective response rate (ORR) of 64.8% versus placebo 1.5% (p<0.0001).

Adverse events were seen in nearly all lenvatinib patients (97.3% on lenvatinib versus 59.5% on placebo) and the most common were hypertension, diarrhoea, fatigue, decreased appetite, decreased weight and nausea.

Source: NHS England