New York's Bristol-Myers Squibb Co. said the U.K. National Institute for Health and Care Excellence rejected its skin cancer drug Opdivo in draft guidance.
The U.K. watchdog rejected Opdivo for use in Britain's National Health Service as a single therapy, or administered after other therapies, for patients with stage 3 or stage 4 melanoma with lymph node involvement or which has spread across the body and whose cancers have been removed through surgery.
Opdivo, or nivolumab, is a checkpoint inhibitor — a tumor-targeting drug that blocks the PD-1 arm on healthy cells from linking up with a partner arm on the surface of cancer cells to spread the disease.
The regulator is uncertain about the effectiveness of the therapy because of a lack of clinical trials comparing Opdivo as an adjuvant therapy, or given after other treatments, to routine surveillance — which is the current standard of care for this type of skin cancer.
While an ongoing phase 3 study, called CheckMate-238, showed that skin cancer patients who received Opdivo lived longer compared to those treated with Bristol-Myers' Yervoy, the regulator still believes the effect of Opdivo on overall survival is uncertain because the study is still progressing.
Cost estimates are also uncertain because of the NICE's issues with Opdivo's efficacy, the regulator said in an appraisal document. The regulator also did not recommend Opdivo to be used within the NHS's Cancer Drugs Fund because it is not possible to assess whether the drug has the potential to be cost effective.
NICE's rejection came weeks after the European Commission approved Opdivo as an additional therapy for certain skin cancer patients.
The closing date for comments regarding the guidance is Sept. 28, while the second meeting for the appraisal committee is slated for Oct. 16.