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Brief Summary

GUIDELINE TITLE

Erlotinib for the treatment of non-small-cell lung cancer.

BIBLIOGRAPHIC SOURCE(S)

  • National Institute for Clinical Excellence (NICE). Erlotinib for the treatment of non-small-cell-lung cancer. London (UK): National Institute for Health and Clinical Excellence (NICE); 2008 Nov. 26 p. (Technology appraisal; no. 87).

GUIDELINE STATUS

This is the current release of the guideline.

** REGULATORY ALERT **

FDA WARNING/REGULATORY ALERT

Note from the National Guideline Clearinghouse: This guideline references a drug(s) for which important revised regulatory and/or warning information has been released.

  • May 8, 2009 - Tarceva (erlotinib): OSI Pharmaceuticals, Inc., Genentech and the U.S. Food and Drug Administration (FDA) notified healthcare professionals of new safety information added to the WARNINGS AND PRECAUTIONS sections of the prescribing information for Tarceva. Gastrointestinal perforation (including fatalities), bullous, blistering and exfoliative skin conditions including cases suggestive of Stevens-Johnson syndrome/toxic epidermal necrolysis, in some cases fatal, and ocular disorders, including corneal perforation or ulceration have been reported during use of Tarceva.
  • September 23, 2008 - Tarceva (erlotinib): OSI Pharmaceuticals and Genentech notified healthcare professionals that cases of hepatic failure and hepatorenal syndrome, including fatalities, have been reported during use of Tarceva, particularly in patients with baseline hepatic impairment. New information has been provided in the revised prescribing information, and other recommendations are included in the WARNINGS and DOSAGE AND ADMINISTRATION sections.

BRIEF SUMMARY CONTENT

 ** REGULATORY ALERT **
 RECOMMENDATIONS
 EVIDENCE SUPPORTING THE RECOMMENDATIONS
 IDENTIFYING INFORMATION AND AVAILABILITY
 DISCLAIMER

 Go to the Complete Summary

RECOMMENDATIONS

MAJOR RECOMMENDATIONS

  1. Erlotinib is recommended, within its licensed indication, as an alternative to docetaxel as a second-line treatment option for patients with non-small-cell lung cancer (NSCLC) only on the basis that it is provided by the manufacturer at an overall treatment cost (including administration, adverse events and monitoring costs) equal to that of docetaxel.
  2. The decision to use erlotinib or docetaxel (as outlined above) should be made after a discussion between the responsible clinician and the individual about the potential benefits and adverse effects of each treatment.
  3. Erlotinib is not recommended for the second-line treatment of locally advanced or metastatic NSCLC in patients for whom docetaxel is unsuitable (that is, where there is intolerance of or contraindications to docetaxel) or for third-line treatment after docetaxel therapy.
  4. People currently receiving treatment with erlotinib, but for whom treatment would not be recommended according to the section above, should have the option to continue treatment until they and their clinicians consider it appropriate to stop.

CLINICAL ALGORITHM(S)

None provided

EVIDENCE SUPPORTING THE RECOMMENDATIONS

TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of evidence supporting the recommendations is not specifically stated.

IDENTIFYING INFORMATION AND AVAILABILITY

BIBLIOGRAPHIC SOURCE(S)

  • National Institute for Clinical Excellence (NICE). Erlotinib for the treatment of non-small-cell-lung cancer. London (UK): National Institute for Health and Clinical Excellence (NICE); 2008 Nov. 26 p. (Technology appraisal; no. 87).

ADAPTATION

Not applicable: The guideline was not adapted from another source.

DATE RELEASED

2008 Nov

GUIDELINE DEVELOPER(S)

National Institute for Health and Clinical Excellence (NICE) - National Government Agency [Non-U.S.]

SOURCE(S) OF FUNDING

National Institute for Health and Clinical Excellence (NICE)

GUIDELINE COMMITTEE

Appraisal Committee

COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

Committee Members: Professor David Barnett, Professor of Clinical Pharmacology, University of Leicester; Dr David W Black, Director of Public Health, Chesterfield PCT; Dr Carol Campbell, Senior Lecturer, University of Teesside; Professor Mike Campbell, Professor of Medical Statistics, University of Sheffield; Professor David Chadwick, Professor of Neurology, Liverpool University; Dr Peter Clark, Consultant Medical Oncologist, Clatterbridge Centre for Oncology, Merseyside; Ms Jude Cohen, Chief Executive, Women's Nationwide Cancer Control Campaign; Dr Christine Davey, Senior Researcher, North Yorkshire Alliance R&D Unit; Dr Mike Davies, Consultant Physician, Manchester Royal Infirmary; Mr Richard Devereaux-Phillips, Public Affairs Manager, Medtronic Ltd; Dr Rachel A Elliott, Lord Trent Professor of Medicines and Health, Nottingham University; Mrs Eleanor Grey, Lay member; Dr Dyfrig Hughes, Reader in Pharmacoeconomics, Centre for Economics and Policy in Health, Bangor University; Dr Catherine Jackson, Professor of General Practice, St Andrews University; Dr Peter Jackson, Clinical Pharmacologist, Sheffield Teaching Hospitals NHS Foundation Trust; Professor Peter Jones, Pro Vice Chancellor for Research and Enterprise, Keele University; Dr Damien Longson, Consultant in Liaison Psychiatry, North Manchester General Hospital; Professor Jonathan Michaels, Professor of Vascular Surgery, University of Sheffield; Dr Eugene Milne, Deputy Medical Director, North East Strategic Health Authority; Dr Martin J Price, Head of Outcomes Research, Janssen-Cilag Ltd; Dr Philip Rutledge, GP and Consultant in Medicines Management, NHS Lothian; Mr Miles Scott, Chief Executive, Bradford Teaching Hospitals NHS Foundation Trust; Professor Mark Sculpher, Professor of Health Economics, University of York; Professor Andrew Stevens, Chair of Appraisal Committee C; Dr Cathryn Thomas, Senior Lecturer, Department of Primary Care and General Practice; Mr William Turner, Consultant Urologist, Addenbrookes Hospital

FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Committee members are asked to declare any interests in the technology to be appraised. If it is considered there is a conflict of interest, the member is excluded from participating further in that appraisal.

GUIDELINE STATUS

This is the current release of the guideline.

GUIDELINE AVAILABILITY

AVAILABILITY OF COMPANION DOCUMENTS

The following are available:

Print copies: Available from the National Health Service (NHS) Response Line 0870 1555 455. ref: N1737. 11 Strand, London, WC2N 5HR.

PATIENT RESOURCES

The following is available:

Print copies: Available from the NHS Response Line 0870 1555 455. ref: N1738. 11 Strand, London, WC2N 5HR.

Please note: This patient information is intended to provide health professionals with information to share with their patients to help them better understand their health and their diagnosed disorders. By providing access to this patient information, it is not the intention of NGC to provide specific medical advice for particular patients. Rather we urge patients and their representatives to review this material and then to consult with a licensed health professional for evaluation of treatment options suitable for them as well as for diagnosis and answers to their personal medical questions. This patient information has been derived and prepared from a guideline for health care professionals included on NGC by the authors or publishers of that original guideline. The patient information is not reviewed by NGC to establish whether or not it accurately reflects the original guideline's content.

NGC STATUS

COPYRIGHT STATEMENT

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.

DISCLAIMER

NGC DISCLAIMER

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