Janssen’s Niraparib Receives the US FDA’s Breakthrough Therapy Designation for Metastatic Castration-Resistant Prostate Cancer

Janssen’s Niraparib Receives the US FDA’s Breakthrough Therapy Designation for Metastatic Castration-Resistant Prostate Cancer

Shots:

  • The breakthrough designation is based on P-II GALAHAD study assessing Niraparib in adult patients with BRCA1/2 gene-mCRPC and DNA-repair gene defects (DRD) prior treated with androgen-receptor targeting therapies and docetaxel
  • The FDA’s BT designation is granted to expedite the development and regulatory review of an investigational medicine that is intended to treat a serious or life-threatening condition
  • Niraparib (PO) is a selective PARP inhibitor, currently being evaluated in P-III MAGNITUDE study assessing niraparib + Zytiga (abiraterone acetate) and prednisone in patients with mPC. Additionally, it is being evaluated in P-Ib/II study of niraparib combination therapies for the treatment of mCRPC

Click here to­ read full press release/ article | Ref: Janssen | Image: WSJ