Decision

Early access to medicines scheme (EAMS) scientific opinion: osimertinib (AZD9291) 40 and 80mg film-coated tablets

Information on the EAMS scientific opinion given to osimertinib (AZD9291) 40 and 80mg film-coated tablets, including the public assessment report.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 7 December 2015
• Last updated: 19 January 2016 — See all updates

This publication was withdrawn on 5 February 2016

The EAMS opinion for osimertinib has been withdrawn as the marketing authorisation has been adopted by the European Commission.

Documents

Osimertinib (AZD9291) 40 and 80mg film-coated tablets EAMS public assessment report (PAR)

PDF, 77.4 KB, 3 pages

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Treatment protocol for patients

PDF, 215 KB, 7 pages

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Treatment protocol for healthcare professionals

PDF, 249 KB, 15 pages

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Treatment protocol on the pharmacovigilance system

PDF, 78 KB, 3 pages

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Details

This positive scientific opinion was issued to AstraZeneca UK Limited for osimertinib (AZD9291) 40 and 80 mg film-coated tablets for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small-cell lung cancer (NSCLC) who have progressed on or after EGFR TKI therapy.

The scientific opinion includes:

• a public assessment report
• a treatment protocol:
  • for healthcare professionals
  • for patients
  • on the pharmacovigilance system

Contact

Information and details regarding patient access

For new patients wishing to access EAMS medicines in England, trusts must submit an application form to england.eams@nhs.net to register the patient with NHS England. The form itself can be requested from the same dedicated EAMS email address. Plans are underway to introduce a web based application form as soon as possible. Trusts will be informed when this is available.

For information about access in Northern Ireland, contact Mark Timoney, Chief Pharmaceutical Officer at Mark.Timoney@dhsspsni.gsi.gov.uk and Joe Magee, Secondary Care Directorate at Joe.Magee@dhsspsni.gov.uk.

For information about access in Scotland contact the Scottish Government Directorate General Health & Social Care email John.Hannah@scotland.gsi.gov.uk and Kathryn.Fergusson@scotland.gsi.gov.uk.

For information about access in Wales, contact the Welsh Government Department of Health and Social Services by emailing Roger Walker Chief Pharmaceutical Officer at Roger.Walker@wales.gsi.gov.uk and Karen Eveleigh, Head of Pharmacy and Prescribing policy at Karen.Eveleigh@wales.gsi.gov.uk.

Published 7 December 2015
Last updated 19 January 2016 + show all updates

1. 19 January 2016

   The EAMS treatment protocols for the patient and HCPs have been updated in line with information received from the EAMS scientific opinion holder.

2. 7 December 2015

   First published.