On the 17th of August 2018, the US FDA approved a new indication for Opdivo® (nivolumab). This time, Opdivo® has been approved for the treatment of patients with metastatic small cell lung cancer (SCLC) whose cancer has progressed after platinum-based chemotherapy and at least one other line of therapy.
This new indication makes Opdivo® the very first treatment option for patients in this specific setting. Small cell lung cancer is one of the two most common types of lung cancer, and accounts for about 10-15% of all lung cancer patients.
The approval of Opdivo® in small cell lung cancer
The approval from the FDA was based on an on-going Phase 1/2 clinical trial called CheckMate -032. The trial set out to measure patients with small cell lung cancer, who had experienced disease progression after platinum-based chemotherapy.
109 patients were involved in the clinical trial, and out of these 109 patients 12 percent responded to the treatment. Among these 12 patients, 11 patients had a partial response and 1 patient had a complete response. While these numbers may sound rather small, it is worth noting that of the patients who responded to the treatment, the median duration of response was 17.9 months.
Based on this data, Opdivo® was approved through FDA’s accelerated approval framework.
Previous approvals from the FDA
This latest approval from the FDA is by no means the first for nivolumab.
Opdivo® already has a rather large portfolio of FDA approvals for various indications across melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC) (see previous article), classical Hodgkin lymphoma (cHL), squamous cell carcinoma of the head and neck (SCCHN), urothelial carcinoma, metastatic colorectal cancer (CRC) and hepatocellular carcinoma (HCC).
Opdivo® (nivolumab) is a registered trademark of Bristol-Myers Squibb