- Bristol-Myers' Opdivo (nivolumab) has been approved by the FDA for second-line treatment of squamous and non-squamous non-small cell lung cancer (NSCLC) tumors in patients whose disease progressed during or after platinum-based chemotherapy.
- The FDA also approved a companion diagnostic, PD-L1 IHC 28-8, to test PD-L1 levels.
- The approval for the expanded indication was granted three months ahead of the official PDUFA date, which was January 2, 2016.
The approval is based on results of an international, open-label, randomized study involving 582 patients with advanced NSCLC, including patients who received either docetaxel alone (standard of care) or docetaxel combined with Opdivo.
Opidvo-treated patients lived on average 12.2 months, compared with 9.4 months for patients treated with standard of care. In addition, 19% of Opdivo-treated patients experienced complete or partial shrinkage of their tumors, with an average treatment effect of 17 months. In contrast, 12% of docetaxel only-treated patients had complete or partial shrinkage of their tumors - an effect that lasted an average of six months.
The results were strong enough to justify an expedited approval three months ahead of PDUFA. The drug continues to maintain an advantage over rival Keytruda in several key respects, including the fact that its NSCLC indication is more broad than Merck's immuno-oncologic.