Idelalisib

Drug Profile

Idelalisib

Alternative Names: CAL-101; GS-1101

Latest Information Update: 12 Nov 2016

Price : $50

At a glance

  • Originator Calistoga Pharmaceuticals
  • Developer Calistoga Pharmaceuticals; Gilead Sciences
  • Class Antineoplastics; Purines; Quinazolinones; Small molecules
  • Mechanism of Action Phosphatidylinositol 3 kinase delta inhibitors
  • Orphan Drug Status

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

    No
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Chronic lymphocytic leukaemia; Follicular lymphoma
  • Phase III Non-Hodgkin's lymphoma
  • Phase II Hodgkin's disease; Mantle-cell lymphoma; Waldenstrom's macroglobulinaemia
  • Phase I Myelofibrosis; Pancreatic cancer
  • Discontinued Allergic rhinitis; Solid tumours

Most Recent Events

  • 25 Jul 2016 The EMA’s Pharmacovigilance Risk Assessment Committee recommends approval of idelalisib in Chronic lymphocytic leukaemia and Follicular lymphoma
  • 22 Jul 2016 The European Medicines Agency’s Committee for Medicinal Products for Human Use recommends approval of idelalisib for Chronic lymphocytic leukaemia and Follicular lymphoma with updated recommendations to minimise the risk of serious infection in European Union
  • 24 Jun 2016 Gilead Sciences terminates a phase III trial in Chronic lymphocytic leukaemia (First-line therapy, Combination therapy) in USA, Australia, Belgium, Bulgaria, Canada, Croatia, Czech Republic, France, Hungary, Italy, Poland, Romania, Spain and United Kingdom (NCT01980888)
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