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Precision Medicine


therapy, as well as early indications of adverse tox- icological effects35,36.


Case studies of Precision Medicine Drugs Herceptin: Herceptin (trastuzumab) is a human- ised monoclonal antibody and targets the HER-2 receptor in breast cancer patients. This drug was developed and sold by Genentech/Roche. The FDA and EMA both approved its use in 1998 and 2000 respectively for the treatment of breast cancer, but only for patients for HER-2 (+) patients. Herceptin became the first Targeted or Precision Medicine Drug to be approved, although at that time such terminology was not in common usage37. The development history of Herceptin is instruc-


tive in the evolution of Targeted and Precision Medicine Drugs. In the late 1980s, Professor Slamon (UCLA) and Professor Gullick (ICR-


London) reported that some human breast cancers manifested overexpression of the HER2 gene, as well as the protein product her-2, resulting in a poor prognosis for the patient. Gullick in conjunc- tion with Dr Barnes (Imperial Cancer Fund Research Unit, Guys Hospital) reported that HER- 2 (+) tumours were much more aggressive than HER-2 (-) tumours37. The fact that her-2 protein was present at high concentrations indicated it was a good target for therapeutic intervention to treat HER-2 positive tumours. Dr Sliwkowski and col- leagues (Genentech) developed a monoclonal anti- body to target her-2 protein, and the antibody was ultimately named Herceptin.


Gleevec: Gleevec (imatinib) is a 2-phenyl amino pyrimidine derivative and acts as a specific inhibitor of a number of tyrosine kinase enzymes.


Table 1: Precision Medicine Drugs approved by FDA in 2017. Data taken and adapted from PMC Progress Report39 BRAND 1 2 3 4 5 6 7 8 9 Kisqali Bavencio Zejula Austedo Ingrezza Brineura Alunbrig Rydapt Imfinzi 10 Nerlynx 11 12 Vosevi Idhifa 13 Mavyret 14 Verzenio 15 Mepsevii 16 Hemlibra Drug Discovery World Summer 2018 DRUG NAME(S) Ribociclib Avelumab Niraparib Deutetrabenazine Valbenazine Cerliponase alfa Brigatinib Midostaurin Durvalumab Neratinib maleate


Sofosbuvir, Velpatasvir Voxilaprevir


Enasidenib Glecaprevir & Pibrentasvir Abemaciclib Vestronidase Emicizumab-kxwh INDICATION(S) Advanced breast cancer Metastatic Merkel cell carcinoma


Recurrent epithelial ovarian, fallopian tube or peritoneal cancers


Huntington’s Disease associated Chorea


Tardive dyskinesia CLN2 type Batten disease Metastatic non-small cell lung cancer Acute myeloid leukaemia Advanced urothelial carcinoma Reoccurring breast cancer Hepatitis C Refractory acute myeloid leukaemia Hepatitis C Advanced breast cancer


Mucopolysaccharidosis type VII (Sly syndrome)


Hemophilia A LABEL BIOMARKER HR and HER2 PD-L1 levels BRCA mutation CYP2D6 CYP2D6 TPP1 ALK FLT3 PD-L1 HER2 HCV genotype IDH2 HCV genotype HR and HER2 MPS VII Factor VIII antibody 13


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