Rucaparib - Clovis Oncology

Drug Profile

Rucaparib - Clovis Oncology

Alternative Names: AG-014699; AG-14699; CO-338; PF-01367338; PF-1367338; Rubraca; Rucaparib phosphate

Latest Information Update: 07 Dec 2017

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At a glance

  • Originator Cancer Research UK
  • Developer Cancer Research UK; Clovis Oncology; Roche; UNICANCER
  • Class 3-ring heterocyclic compounds; Antineoplastics; Azepines; Indoles; Small molecules
  • Mechanism of Action Poly(ADP-ribose) polymerase inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Ovarian cancer
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Ovarian cancer
  • Preregistration Fallopian tube cancer; Peritoneal cancer
  • Phase III Prostate cancer
  • Phase II Breast cancer; Pancreatic cancer
  • Phase I Gynaecological cancer; Solid tumours
  • Suspended Malignant melanoma

Most Recent Events

  • 05 Dec 2017 Clovis intends to file a variation to the Marketing Authorization Application for Ovarian cancer (Maintenance therapy) in Europe in early 2018, contingent on a potential approval in Europe for this indication
  • 05 Dec 2017 FDA assigns PDUFA action date of 06/04/2018 for rucaparib for Ovarian cancer, Peritoneal cancer, Fallopian tube cancer (Second-line therapy or greater, Recurrent, Maintenance therapy)
  • 05 Dec 2017 Rucaparib receives priority review status for Ovarian cancer, Peritoneal cancer, Fallopian tube cancer (Second-line therapy or greater, Recurrent, Maintenance therapy) in USA
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