Compared to the existing standard of care chemotherapy ‘docetaxel’, the company noted that nivolumab is expected to offer significant superiority in survival rates.
The approval of nivolumab, a PD-1 (programmed death-1) immune checkpoint inhibitor, represents an important development in treatment for this group of patients.
Nivolumab is the first in a new class of medicines to be approved for lung cancer and it works by harnessing the ability of the immune system to find and fight cancer.
The Royal Marsden Consultant Thoracic Medical Oncologist Dr Sanjay Popat said: "This group of patients with relapsed squamous-type lung cancer represents a considerable unmet medical need in the UK, as chemotherapy has been their main option until now.
"The launch of nivolumab is a milestone that changes the treatment landscape from one where existing treatment options have offered modest improvements in survival, to one where lung cancer patients have an additional option which can significantly extend survival."
The approval was based on results from the pivotal Phase III, CheckMate -017 study, which evaluated the efficacy and safety of nivolumab in adult patients with advanced squamous-cell NSCLC whose disease had progressed during or after one prior platinum containing chemotherapy regimen.
A total of 272 patients were randomly assigned to receive either nivolumab (3mg/kg every two weeks) or docetaxel (75mg/m2 of body-surface area every three weeks).