Date: 2014-12-19
Type of information: Granting of a Market Authorisation in the US
Product name: BRACAnalysis® as a companion diagnostic with olaparib
Compound: BRACAnalysis® as a companion diagnostic with olaparib
Therapeutic area: Cancer - Oncology
Action mechanism:
Company: Myriad Genetics (USA - UT)
Disease: ovarian cancer
Latest news: * On December 19, 2014, the FDA approved olaparib capsules (Lynparza®, AstraZeneca Pharmaceuticals LP) as monotherapy for the treatment of patients with deleterious or suspected deleterious germline BRCA mutated (gBRCAm) (as detected by an FDA-approved test) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. Concurrent with this action, FDA approved the BRACAnalysis CDx (Myriad Genetics) for the qualitative detection and classification of variants in the BRCA1 and BRCA2 genes. * On April 7, 2014, Myriad Genetics has announced that it has submitted the first module of a premarket approval (PMA) application to the FDA for the use of BRACAnalysis® testing as a companion diagnostic with olaparib. Olaparib is an investigational, orally active poly-ADP ribose polymerase (PARP) inhibitor being developed by AstraZeneca.Consistent with the FDA\'s modular premarket approval process, Myriad submitted the first of four PMA modules and is working to submit the remaining modules according to a pre-specified plan. The collaboration between Myriad and AstraZeneca on olaparib began in 2007. Since then, the two companies have shared scientific insight and worked closely together to move cancer research forward. In 2012, Myriad made strides in developing BRACAnalysis as a companion diagnostic by retrospectively genotyping patients in a previously completed Phase 2 study of olaparib. Last September, Myriad Genetics has entered into an expanded, nonexclusive global collaboration agreement with AstraZeneca to provide companion diagnostics for the olaparib Phase 3 clinical development program.
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: 2014-12-19
UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
