The US Food and Drug Administration (FDA) has granted approval for Bristol-Myers Squibb‘s Opdivo (nivolumab) injection for intravenous use, to treat patients with metastatic non-small cell lung cancer (NSCLC) with progression or after platinum-based chemotherapy.

The company said that patients with epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumour aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Opdivo.

The approval is the third for Opdivo in the US this year and is based on results of the Phase III CheckMate -057 trial, which showed superior OS benefit for Opdivo versus docetaxel in previously treated metastatic NSCLC.

Opdivo is the only PD-1 therapy to have been studied in a Phase III trial of patients with previously treated squamous NSCLC and a separate Phase III trial of patients with previously treated non-squamous NSCLC.

"Non-small cell lung cancer is a difficult to treat disease with high mortality, and patients with squamous and non-squamous NSCLC often respond differently to treatment."

In the trial, Opdivo said 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.

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"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."

The open-label, randomised CheckMate -057 trial evaluated Opdivo 3mg/kg administered intravenously every two weeks versus 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.

Yale Cancer Center and Smilow Cancer Hospital Medical Oncology chief Dr Roy Herbst said: "Non-small cell lung cancer is a difficult to treat disease with high mortality, and patients with squamous and non-squamous NSCLC often respond differently to treatment.

"Opdivo is becoming an important treatment option for more patients with previously treated metastatic NSCLC, and is a welcome addition to our therapy of this disease."

BMS has also collaborated with Dako, an Agilent Technologies company, to develop PD-L1 IHC 28-8 PharmDx, a test used to assess PD-L1 expression in the CheckMate -057 trial.

Dako has secured approval from the FDA for the new test 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.

The test is now approved as a complementary diagnostic, which will provide additional information for physicians and these tests are distinct from companion diagnostics, which are essential for safe and effective use of a drug.