FDA grants breakthrough therapy status for Merck’s lung cancer drug Keytruda

Keytruda is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2.

The breakthrough status for Keytruda is to treat these patients whose disease has progressed on or for those who have undergone platinum-based chemotherapy.

The company said that this is the second breakthrough therapy designation granted for Keytruda. Previously it was granted the designation for advanced melanoma.

In the US, Keytruda is indicated at a dose of 2mg/kg every three weeks to treat patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.

Merck Research Laboratories president Dr Roger Perlmutter said: "The FDA’s Breakthrough Therapy Designation of Keytruda underscores that new treatment approaches for advanced non-small cell lung cancer continue to be needed.

"Our data investigating the use of KEYTRUDA in this difficult-to-treat malignancy are very encouraging, and we look forward to working closely with the FDA to expedite our clinical program."

The FDA breakthrough status is based on data from the ongoing Phase Ib KEYNOTE-001 trial.

Currently, Keytruda is being evaluated across more than 30 types of cancers, as monotherapy and in combination.

The company is conducting two Phase II and III trials in advanced lung cancer (KEYNOTE-010 and KEYNOTE-024) and an additional Phase III trial (KEYNOTE-042) is scheduled to start in the fourth quarter of 2014.

Image: Micrograph of a squamous carcinoma, a type of non-small-cell lung carcinoma. Photo: courtesy of Nephron.