FDA

Accelerating Immuno-Oncology Therapies to Market

In their 2015 industry report, the Pharmaceutical Research and Manufacturers of America (PhRMA) estimated over 800 cancer therapies were in the industry pipeline—citing that approximately 80% of these drugs have the potential to be first-in-class medicines. One of the most groundbreaking areas in oncology today is checkpoint inhibitor immuno-oncology (I-O) treatments, with the American Society of Clinical Oncology (ASCO) naming immunotherapy as its 2016 Advance of the Year. Checkpoint inhibitor I-O treatments unlock immune system cells, allowing the cells to recognize and fight cancer tumors, and have shown early efficacy gains that have given hope to many oncology researchers, physicians, and patients. An exciting breakthrough that raises the question—what is the fastest and safest way to get these new treatments to patients?

Science vs. Marketing

A Wall Street Journal article on March 13 reported that Bristol-Myers Squibb’s cancer drug Opdivo® has outperformed Merck’s similar drug, Keytrudo®, by falling back on an “old, mass-marketing approach.” Merck’s product is paired with a diagnostic test used to identify patients expressing the PD-L1 protein, in whom the drug would be the most effective. Merck’s trials only included patients expressing this protein, and the FDA approved the drug only in those who test positive for it.