FDA Approves Third Indication for BMS’ Opdivo

The FDA last week approved a third indication for Bristol-Myers Squibb’s Opdivo, this time to treat metastatic non-squamous non-small cell lung cancer that has progressed during or after platinum-based chemotherapy.

The approval means the PD-1 inhibitor can be used to treat both main types of NSCLC — squamous and non-squamous. Opdivo won the squamous indication in March.

The new indication comes a week after Merck’s Keytruda gained FDA approval to treat both kinds of NSCLC, becoming the first PD-1 inhibitor to do so. However, Keytruda is limited to patients whose tumors express the PD-L1 protein and Opdivo is not, potentially giving it a larger patient population.

Forecasts for Opdivo and Keytruda are about $9 billion and $5 billion, respectively, in 2020, S&P Capital IQ analyst Jeffrey Loo said.

The approval was based on a clinical study showing Opdivo clearly extended overall survival compared with docetaxel. BMS cut short the comparative arm of the study in April after the interim results showed a clear benefit over chemotherapy.

Opdivo was granted breakthrough therapy designation and priority review status for the new indication. The approval comes roughly three months ahead of the FDA’s decision target date of Jan. 2, 2016.

In addition to the two NSCLC indications, Opdivo is approved for previously treated advanced melanoma. More indications could be on the horizon, as the FDA is considering the drug’s sBLA for untreated advanced melanoma, and last month it was awarded breakthrough therapy designation for metastatic renal cell carcinoma. — Kellen Owings