Date: 2011-12-18
Type of information: Granting of a Market Authorisation in the US
Product name: HER2 CISH pharmDx® Kit
Compound:
Therapeutic area: Cancer - Oncology - Diagnostic
Action mechanism: HER2 CISH pharmDx® Kit is a dual color chromogenic assay designed to quantitatively determine HER2 gene amplifications in breast cancer tissue specimens, using a bright field microscope for the HER2 scoring. In a subset of patients (20-25%) with breast cancer, the HER2 gene is amplified. HER2 CISH pharmDx® Kit is indicated as an aid in the assessment of patients for whom Herceptin® treatment is being considered.
Company: Dako (Denmark)
Disease: assessment of breast cancer patients for whom treatment with Herceptin® is being considered
Latest news: * On December 14, 2011, Dako has received approval from the FDA to market HER2 CISH pharmDx® Kit in the United States. This new diagnostic test is specifically developed as an aid in the assessment of breast cancer patients for whom treatment with Herceptin® is being considered. It allows pathologists to perform validated FISH tests and score the results using readily available bright field microscopes.
A recent study comprising 365 breast cancer patients showed 98.3 and 97.7 percent concordance between results obtained with HER2 CISH pharmDx® Kit and two FDA-approved HER2 FISH tests. This is well over the threshold of 95 percent recommended by the American Society of Clinical Oncology (ASCO) and the College of American Pathologists.
HER2 CISH pharmDx® Kit was CE-IVD marked in June 2010. The product has now received FDA's approval and will be available to US customers as of February 2012.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2011-12-14
UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
