The evo­lu­tion of pre­ci­sion medicine

Jamaica Gleaner - - SOMETHING EXTRA -

HERCEPTIN, THE orig­i­nal ge­netic drug, showed that not all can­cers are alike.

Herceptin is the orig­i­nal tar­geted­drug 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 post­surgery treat­ment of early-stage HER2­pos­i­tive 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.

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