Herceptin- A case of Perseverance in Drug Development

From concept to commercialisation,  drug development takes decades.  The process demands a concerted, multi-disciplinary approach involving several agencies.  The time span is too long for   people and management  to remain committed to the cause. That almost happened to  Herceptin,  the best drug now available  in the market for HER2 positive  breast cancer.  Now in living tissues   HER-2 protein is the  biochemical signal for  cells to grow and multiply.   When the levels of   HER-2, become abnormally high, cells are  provoked  to  mushroom at an alarming rate and that is cancer. This type of cancer is also referred to  as HER2 positive.  Herceptin moieties  attach themselves to HER2 receptors and suppress them. The uniqueness of  herceptin  is that it doesn't have the debilitating side effects of either chemotherapy or radiotherapy. 

Herceptin,  has the generic name Trastuzumab which in WHO nomenclature is loaded with information. While Tras is a euphonic prefix,  tu stands for miscellaneous tumours, zu for   humanised and mab for   monoclonal antibody.  This drug was  developed jointly by  scientists at the biotech company  Genentech and the University of California,Los Angeles.  Axel Ullrich of Genentech and Dennis Slamon of UCLA were at the helm in the beginning. When Ullrich moved to Max Planck Institute of Biochemistry, it fell on Slamon to see the project through.  In retrospect, the timeline presents a hazzle free smooth roadmap, as easy as connecting the dots: for example  the seventies provided  the concept of monoclonal antibodies; by the eighties  the HER2 gene was cloned  and its role in   breast cancer  established; beginning of  nineties saw the  design and creation of herceptin and by 1998 the FDA approval was in place.  But it wasn't a smooth sail at all.  Science journalist Robert Bazell tells the story in great detail in  his book  Her-2 :The making of Herceptin, a revolutionary treatment for breast cancer. Scientific hurdles apart, there were parties with vested interests. 

New England Journal of Medicine in its review described the book  as  the story of the triumph of an inspired clinician against great opposition, which included his own colleagues, grant-awarding agencies, and pharmaceutical companies. Robin M. Henig , wrote      in    The New York Times     : Populated with single-minded scientists, clueless biotech company executives and women stricken with a particularly vicious form of breast cancer -- one that rages so fiercely that it can erupt along the fault lines of a mastectomy incision even before the scar heals -- ''Her-2'' is about the making and marketing of an entirely new kind of cancer therapy. 
Later the book was made into a telefilm " Living Proof" 

REFERENCES:

1. Genentech Her2 Story

2. HER-2: The making of Herceptin, a Revolutionary Treatment for  Breast cancer by Robert Bazell, Random House 1988 ISBN 13: 978-0812991840