FDA Grants Accelerated Approval to Merck’s Keytruda

October 8, 2015

The FDA last week granted Merck’s Keytruda accelerated approval to treat advanced non-small cell lung cancer, making it the first PD-1 inhibitor approved for that indication.

Approval was based on a study in which 41 percent of patients treated with Keytruda (pembrolizumab) saw their tumors shrink, with the effect lasting two to nine months.

The approval includes a companion diagnostic, the PD-L1 IHC 2C3 pharmDx, marketed by Dako North America. It is the first test designed to detect PD-L1 expression in non-small cell lung tumors.

The approval of Keytruda came one day after the FDA approved Bristol-Myers Squibb’s PD-1 inhibitor Opdivo (nivolumab) in combination with Yervoy (ipilimumab) to treat advanced melanoma — the first ever approval of an immuno-oncology combination.

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

Keytruda received FDA breakthrough therapy designation for advanced non-small cell lung cancer in October 2014. It was initially approved for advanced melanoma in September of that year. — Jonathon Shacat