Herceptin is the original targeted drug therapy. The medication, which targets the HER2 protein associated with an aggressive form of breast cancer, was developed by the biotech company Genentech and won approval from the U.S. Food and Drug Administration in 1998. It has been used to treat more than two million patients worldwide and has generated global sales of more than $64 billion for the Swiss pharma giant Roche, which owns Genentech and markets Herceptin outside the U.S. Here’s how the pioneer of precision medicine has evolved.
National Institutes of Health shows that HER2 gene is frequently amplified in human breast tumor cells.
Genentech scientists, having cloned the first human HER2 gene earlier, create Herceptin by humanizing a mouse antibody directed at HER2. Third parties later estimate Genentech’s development costs to be $150 to $200 million.
Genentech requests authorization from the FDA to administer Herceptin as an investigational drug.
Clinical trials look at the safety and efficacy of Herceptin alone or with chemotherapy for people with HER2-positive metastatic breast cancer.
Genentech announces collaboration with diagnostics company Dako to develop commercial test to identify patients who overexpress HER2.
Genentech requests FDA permission to market Herceptin. FDA designates it a “Fast Track” and “Priority Review” product, which means it fills an unmet medical need for a serious condition and will be reviewed within six months rather than the standard 10.
FDA approves Herceptin for the treatment of HER2-positive metastatic breast cancer and approves a diagnostic test to help identify patients.
First European approval.
FDA approves three different Herceptin-based regimens for post-surgery treatment of early-stage HER2-positive breast cancer. Approval for gastric cancer follows.
First patent for Herceptin expires in Europe. Following the lead of an Indian biotech firm that got a highly similar version of the drug approved in 2013, a South Korean company receives approval for a “biosimilar” that shows no clinically meaningful difference in safety or effectiveness from the original product. Other Asian approvals follow.
Shortly after President Obama announces his $215 million research project on precision medicine, the World Health Organization adds Herceptin to its list of essential medicines for low- and middle-income countries.
First patent for Herceptin is scheduled to expire in the U.S.