Drug Profile


Alternative Names: CP-358774; CP-358774-01; Erlotinib hydrochloride; NSC-718781; OSI-774; R-1415; RG-1415; RO-508231; Ro50-8231; Tarceva

Latest Information Update: 21 Mar 2017

Price : $50

At a glance

  • Originator OSI Pharmaceuticals
  • Developer Chugai Pharmaceutical; Genentech; OSI Pharmaceuticals; Polyphenon Pharma; Roche; SCRI Development Innovations
  • Class Alkynes; Antineoplastics; Quinazolines; 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.

    Yes - Glioblastoma
  • 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.

  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Non-small cell lung cancer; Pancreatic cancer
  • Phase III Ependymoma; Head and neck cancer
  • Phase II Bladder cancer; Brain metastases; Glioblastoma; Gynaecological cancer; Squamous cell cancer
  • Phase I/II Myelodysplastic syndromes
  • Preclinical Cancer metastases
  • No development reported Anaplastic astrocytoma; Bronchiolo-alveolar adenocarcinoma
  • Discontinued Breast cancer; Colorectal cancer; Hepatocellular carcinoma

Most Recent Events

  • 01 Jan 2017 OSI Pharmaceuticals and Genentech terminates a phase II trial due to slow accrual in Head and neck cancer (Combination therapy, Metastatic disease, Second-line therapy or greater) in USA (PO) (NCT00392665)
  • 01 Dec 2016 OSI Pharmaceuticals completes a phase II trial in Non-small cell lung cancer (Combination therapy, Late-stage disease, Metastatic disease, Second-line therapy or greater) in USA (PO) (NCT00499655)
  • 01 Dec 2016 Roche terminates the TALISMAN trial in Non-small cell lung cancer (second-line therapy) in Italy due to slow enrolment of patients (NCT01204697)
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at so we can help.

Back to top