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FDA Approves Companion Dx for PD-L1 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-L1 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.

© 2020 Foley & Lardner LLPNational Law Review, Volume VII, Number 285


About this Author

Antoinette F. Konski, Intellectual Property Attorney, Foley Lardner Law Firm

Antoinette F. Konski is a partner and intellectual property lawyer with Foley & Lardner LLP. Ms. Konski works with life science clients, creating and optimizing value in intellectual property portfolios encompassing technologies that include personalized medicine, regenerative and stem cell biology, antibodies, immunology, gene therapy, nanotechnology, diagnostics, small molecules and drug delivery. She represents public and private companies and universities. Ms. Konski currently serves as the firm’s Silicon Valley IP office chairperson, vice chair of the Chemical,...