Tue | Oct 17, 2017

Tech Times | The evolution of precision medicine

Published:Monday | October 3, 2016 | 12:00 AM

Herceptin, the original genetic drug, showed that not all cancers are alike.

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 US 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 US$64 billion for the Swiss pharma giant Roche, which owns Genentech and markets Herceptin outside the US. Here's how the pioneer of precision medicine has evolved.

 

1985

 

National Institutes of Health shows that HER2 gene is frequently amplified in human breast tumor cells.

 

1990

 

Genentech scientists, having cloned the first human HER2 gene earlier, create Herceptin by humanising a mouse antibody directed at HER2. Third parties later estimate Genentech's development costs to be $150 to $200 million.

 

1992

 

Genentech requests authorisation from the FDA to administer Herceptin as an investigational drug.

 

1992-1998

 

Clinical trials look at the safety and efficacy of Herceptin alone or with chemotherapy for people with HER2-positive metastatic breast cancer.

 

March 1998

 

Genentech announces collaboration with diagnostics company Dako to develop commercial test to identify patients who overexpress HER2.

 

May 1998

 

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.

 

September 1998

 

FDA approves Herceptin for the treatment of HER2-positive metastatic breast cancer and approves a diagnostic test to help identify patients.

 

August 2000

 

First European approval.

 

2006-2008

 

FDA approves three different Herceptin-based regimens for post-surgery treatment of early-stage HER2-positive breast cancer. Approval for gastric cancer follows.

 

2014

 

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.

 

May 2015

 

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.

 

2019

 

First patent for Herceptin is scheduled to expire in the US.