Myriad to File sPMA to the US FDA of BRACAnalysis CDx as a Companion Diagnostic for Lynparza (olaparib) to Treat Metastatic Castrate-Resistant Prostate Cancer in Men

Myriad to File sPMA to the US FDA of BRACAnalysis CDx as a Companion Diagnostic for Lynparza (olaparib) to Treat Metastatic Castrate-Resistant Prostate Cancer in Men

Shots:

  • Myriad to seek approval based on the P-III PROfound results assessing Lynparza vs enzalutamide or abiraterone acetate in patients with metastatic castration-resistant prostate cancer who have failed prior treatment with the hormonal agent with homologous recombination repair gene mutations
  • In 2007, Myriad & AstraZeneca entered into collaboration on Lynparza and has resulted in multiple regulatory approvals for BRACAnalysis CDx as companion diagnostic of Lynparza
  • BRACAnalysis CDx is an in vitro diagnostic intended to detect & classify variants in the protein-coding regions and intron/exon boundaries of the BRCA1 and BRCA2 genes utilizing genomic DNA obtained from blood specimen collected in EDTA

Click here to­ read full press release/ article | Ref: Globe NewsWire | Image: Pharma Journalist