FDA Approves Companion Dx for PD-1 Inhibitor

According to the American Cancer Society (“ACS”), lung cancer (both small cell and non-small cell) is the second most common cancer in both men and women (not counting skin cancer). About 14% of all new cancers are lung cancers and 85 % of those are non-small cell lung cancers (NSCLCs).

A New Option for NSCLC Patients

The US Food and Drug Administration (FDA) recently helped NSCLC patients fight this disease when the Agency approved Merck’s PD-1 inhibitor Keytruda^® (pembrolizumab) as a first line treatment for metastatic NSCLC with high levels of PD-L1. The drug also was approved for NSCLC patients previously treated with a tumor proportion score of at least 1 %. The drug previously had been approved only as a second line treatment for this cancer.

Just one day after Merck’s approval, FDA approved Dako’s (a subsidiary of Agilent) companion diagnostic co-developed with Merck. The diagnostic identifies patients that are appropriate for Keytruda^® therapy by determining PD-L1 expression status.

Clinical Adoption of Companion Diagnostics

Personalized medicine relies on accurate and reliable diagnostics to identify patients who will benefit from a therapy or treatment. The Merck/Dako partnership is yet another example of a successful partnership between drug and diagnostic developers. As reported by the Personalized Medicine Coalition, for the last three years, approximately 25% of all new drugs approved by FDA are personalized medicines that link a diagnostic and treatment. Thus, the Merck/Dako partnership and approval is yet another example of the trend toward the adoption of personalized medicine.