NICE Believes Pembrolizumab Is Worth It in Treatment-Naïve Melanoma Patients

A final draft guidance from UK’s National Institutes for Health and Care Excellence (NICE) has given the go-ahead for Merck’s pembrolizumab to be used as monotherapy in treatment-naïve individuals with advanced skin cancer. The guidance does indicate that pembrolizumab (Keytruda) is an option in adults “when the company provides pembrolizumab with the discount agreed in the patient access scheme.”

This announcement comes on the heels of an earlier announcement this week recommending pembrolizumab in advanced melanoma patients who are refractory to ipilimumab or a BRAF or MEK inhibitor (when they harbor a BRAF V600 mutation).

According to Gillian Leng, deputy chief executive at NICE, “The incidence of malignant melanoma has increased fivefold since the mid-1970s in the UK, with around 37 new cases diagnosed every dayii. We are, therefore, pleased to be able to recommend pembrolizumab as an option for some people with the disease that has not been previously treated with ipilimumab, in final draft guidance. I am sure this will be welcome news to patients and healthcare professionals alike.”

Exactly a year back, pembrolizumab was granted FDA approval for advanced melanoma in patients who have failed on other drugs. However, use in treatment-naïve advanced melanoma patients is currently only allowed in Europe.

At the beginning of the month, the drug won its victory in the United States for lung cancer. Developed with a companion diagnostic for PD-L1 expression, the FDA granted accelerated approval to pembrolizumab in patients with advanced (metastatic) non-small cell lung cancer who had progressed following treatment and those who had tumors expressing PD-L1. The companion diagnostic, developed by Dako, is called the PD-L1 IHC 22C3 pharmDx test.

The final guidance in the UK for use in treatment-naïve melanoma patients will be out in November.