The US Food and Drug Administration (FDA) has accepted Bristol-Myers Squibb Company’s (BMY) supplemental biologics licence application (sBLA) for Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab) to treat first-line advanced non-small cell lung cancer (NSCLC).
The sBLA was submitted to use the combination to treat NSCLC patients with tumour mutational burden (TMB) at or above ten mutations per megabase (mut/Mb).
The target FDA action date is 20 February, next year.
Bristol-Myers Squibb thoracic cancers development lead Sabine Maier said: “Lung cancer is a complex disease, and we believe multiple treatment approaches, including those that are biomarker-driven, are needed to help individual patients.
“We look forward to working with the FDA throughout the review process to bring this important treatment option to patients.”
The sBLA was based on the results from Part 1 of CheckMate -227, a Phase III study on a population of first-line NSCLC patients with TMB of more than ten mut/Mb.
The trial assesses Opdivo-based regimens against platinum-doublet chemotherapy in patients with first-line advanced non-small cell lung cancer across squamous and non-squamous tumour histologies.
It consists of two parts with the study’s ongoing second part.
Data of the study was published in The New England Journal of Medicine, as well as presented at the American Association for Cancer Research Annual Meeting 2018.
According to World Health Organization, lung cancer is responsible for nearly 1.7 million deaths every year.
The NSCLC is one of the most common forms of lung cancer and represents nearly 85% of diagnoses.