Laromustine

Drug Profile

Laromustine

Alternative Names: 101M; Cloretazine; Onrigin; VNP 4010M; VNP40101M

Latest Information Update: 02 Mar 2010

Price : $50

At a glance

  • Originator Yale University
  • Developer Vion Pharmaceuticals
  • Class Antineoplastics; Hydrazines; Small molecules; Sulfonamides
  • Mechanism of Action Alkylating agents
  • Orphan Drug Status

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

    Yes - Acute myeloid leukaemia
  • 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.

    Acute myeloid leukaemia

Highest Development Phases

  • Suspended Acute myeloid leukaemia; Glioma; Myelodysplastic syndromes
  • Discontinued Chronic lymphocytic leukaemia

Most Recent Events

  • 27 Feb 2010 Vion receives an FDA response relating to the SPA for the phase II/III trial in Acute myeloid leukaemia
  • 13 Jan 2010 Vion files a Special Protocol Assessment for a phase II//III trial of laromustine in combination with low-dose Ara-C in elderly patients with newly diagnosed Acute myeloid leukaemia in USA
  • 15 Dec 2009 Vion receives complete response letter from the FDA for laromustine in Acute myeloid leukaemia
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