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news.Bristol-Myers Squibb (BMS) has received approval from the US Food and Drug Administration (FDA) for Opdivo (nivolumab) injection, for intravenous use, to treat patients with metastatic non-small cell lung cancer (NSCLC).
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Opdivo can be used for treatment of NSCLC with progression on or after platinum-based chemotherapy.
According to the company, patients with epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Opdivo.
In the US, the approval is the third for Opdivo this year and is based on the results of the Phase III CheckMate -057 trial which showed superior OS benefit for Opdivo vs. docetaxel in previously treated metastatic NSCLC.
In the open-label, randomized trial, Opdivo claimed to have shown superior overall survival (OS) in previously treated metastatic non-squamous NSCLC compared to chemotherapy, with a 27% reduction in the risk of death, based on a prespecified interim analysis.
Bristol-Myers Squibb Worldwide Markets head and senior vice-president Murdo Gordon said: "Improving survival for cancer patients represents the ultimate goal of treatment.
"With today’s FDA approval, it is encouraging to know that Opdivo will be available to significantly more patients with metastatic NSCLC, helping to improve treatment outcomes for patients who have been previously treated.
"We hope that our efforts to bring innovative Immuno-Oncology treatments forward for patients will help increase survivorship and positively impact the lung cancer community."
CheckMate -057 evaluated Opdivo 3mg/kg administered intravenously every two weeks vs. Docetaxel 75mg/m2 administered intravenously every three weeks, in patients with metastatic non-squamous NSCLC who had experienced disease progression during or after one prior platinum doublet-based chemotherapy regimen.
Separately, BMS has entered into partnership with an Agilent Technologies company, Dako, to develop PD-L1 IHC 28-8 PharmDx, a test which was used to assess PD-L1 expression in the CheckMate -057 trial.
Dako has secured an approval from the FDA for the new test as a complementary diagnostic that can identify PD-L1 expression levels on the surface of NSCLC tumor cells and provide information on the survival benefit with Opdivo for patients with non-squamous NSCLC.