Bristol-Myers Squibb announced Friday that the FDA granted accelerated approval to Opdivo (nivolumab) for patients with metastatic small-cell lung cancer (SCLC), whose disease has progressed after platinum-based chemotherapy and at least one other line of therapy. The company noted that the PD-1 inhibitor is the only immuno-oncology treatment authorised in SCLC, while it is the first new medicine cleared for the disease in nearly 20 years.
The FDA accepted the filing for review in April, granting it priority review. The approval is supported by data from the SCLC cohort of the Phase I/II CheckMate -032 trial, with results showing that 12 percent of patients responded to treatment with Opdivo, regardless of PD-L1 expression. Bristol-Myers Squibb noted that of the 13 patients who responded, 12 had a partial response and one subject had a complete response. The company added that among these patients, the median duration of response was 17.9 months.
Opdivo was initially awarded FDA accelerated approval in 2014 for use in patients with unresectable or metastatic melanoma who are no longer responding to other therapies. The drug has since been authorised for a number of other indications, including certain patients with metastatic non-small cell lung cancer and those with recurrent or metastatic squamous cell carcinoma of the head and neck. Earlier this year, the FDA approved Bristol-Myers Squibb's request to update the dosing schedule to once every four weeks for most indications.
Last month, Bristol-Myers Squibb reported that second-quarter sales of Opdivo jumped 36 percent year-over-year to $1.6 billion, coming in above analyst estimates.
To read more Top Story articles, click here.