B-MS builds up Opdivo's latest approval

The US Food and Drug Administration (FDA) has approved a new indication for Opdivo (nivolumab) based on early-stage data.

The PD-1 inhibitor from US pharma major Bristol-Myers Squibb (NYSE: BMY) has become the first immune-oncology drug to be approved for patients with metastatic small cell lung cancer (SCLC) whose cancer has progressed after platinum-based chemotherapy and at least one other line of therapy.

Data on overall response rate and duration of response from a Phase I/II trial was enough for the FDA to approve the indication under accelerated approval.