Rociletinib

Drug Profile

Rociletinib

Alternative Names: AVL-301; CNX-419; CO-1686; EMSI programme; Xegafri

Latest Information Update: 08 Dec 2016

Price : $50

At a glance

  • Originator Avila Therapeutics
  • Developer Clovis Oncology; Genentech
  • Class Acrylamides; Antineoplastics; Pyrimidines; Small molecules
  • Mechanism of Action Epidermal growth factor receptor antagonists
  • 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

  • Preregistration Submission Withdrawal Non-small cell lung cancer

Most Recent Events

  • 16 May 2016 Discontinued after receiving CRL from the US FDA - Preregistration for Non-small cell lung cancer (Late-stage disease, Metastatic disease, Monotherapy, Second-line therapy or greater) in USA (PO)
  • 16 May 2016 Clovis Oncology receives complete response letter from the FDA for rociletinib in Non-small cell lung cancer (Late-stage disease, Metastatic disease, Monotherapy, Second-line therapy or greater) in USA (Clovis Oncology Form 10Q, filed in August 2016)
  • 05 May 2016 Discontinued - Phase-I for Non-small cell lung cancer in Japan (PO)
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