FDA Approved Opdivo for Treating Metastatic Small-Cell Lung Cancer

Bristol-Myers Squibb Company announced that its immuno-oncology drug Opdivo obtained the FDA approval 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.

The approval was based on positive overall response rate and duration of response from the SCLC cohort of the phase I/II CheckMate-032 trial. The data from the study showed that out of 109 patients receiving Opdivo after platinum-based chemotherapy and at least one other prior line of therapy, 12% responded to the treatment based on the assessment by Blinded Independent Central Review (BICR), regardless of PD-L1 expression.

Per the company, Opdivo is now the first immuno-oncology treatment approved for small cell lung cancer (SCLC) in patients who received platinum-based chemotherapy and at least one other line of therapy. SCLC accounts for 10% to 15% of all lung cancers. About 27,000 cases of SCLC are expected to be diagnosed in 2018 in the United States.

Opdivo became the first PD-1 immune checkpoint inhibitor to gain regulatory approval in July 2014. It is currently approved in several countries including the United States, the EU and Japan for several cancer indications. Opdivo became the first PD-1 inhibitor to be approved for a hematological malignancy — classical Hodgkin lymphoma — in both the United States (May 2016) and the EU (November 2016).

In November 2016, Opdivo gained the FDA approval for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (“SCCHN”) with disease progression on or after platinum-based therapy.  The drug has been performing impressively due to demand resulting from the rapid commercial acceptance for several indications including melanoma, renal cell carcinoma and second-line non-small-cell lung cancer (“NSCLC”). The FDA also approved Opdivo for intravenous use in patients with hepatocellular carcinoma (HCC) and first-line RCC in the United States.