Collection

Early access to medicines scheme (EAMS): scientific opinions

Information on granted EAMS scientific opinions, including the public assessment report and treatment protocols.

From:
Medicines and Healthcare products Regulatory Agency
Published
3 June 2015
Last updated
31 May 2024 — See all updates

See expired scientific opinions.

Updates to this page

Published 3 June 2015
Last updated 31 May 2024 + show all updates

  1. 'Dostarlimab in the treatment of endometrial cancer' moved to Expired EAMS page: EAMS SO expired: 16 October 2023

  2. Removed 'Glofitamab in the treatment of diffuse large B-cell lymphoma (DLBCL)" from currently granted EAMS.

  3. Moved cipaglucosidase to the expired page for EAMS SO

  4. Added the following to 'Current EAMS' list: - Glofitimab in the treatment of diffuse large B-cell lymphoma - Dostarlimab in the treatment of endometrial cancer

  5. Removed Risankizumab due to Granting of marketing authorisation

  6. Moved 'Lutetium (177Lu) vipivotide tetraxetan in the treatment of prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC)' to expired EAMS SO. Reason: Granting of marketing authorisation

  7. Removed Voxelotor from 'Current EAMS' - Moved to 'Expired'.

  8. Added SO for fgartigimod alfa in the treatment of myasthenia gravis gmg.

  9. Removed Abrocitnib from Current EAMS

  10. Added 'Lutetium (177Lu) vipivotide tetraxetan in the treatment of prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC)' to the list of current EAMs.

  11. Added Decision "Voxelotor in the treatment of sickle cell disease"

  12. Added decision for Asciminib in the treatment of chronic myeloid leukaemia

  13. Removed nivolumab in combination with fluoropyrimidine- and platinum-based combination chemotherapy for the first-line treatment of adult patients with HER2 negative (or undetermined) advanced or metastatic gastric, gastro-oesophageal junction or oesophageal adenocarcinoma.as it has now been granted a marketing authorisation.

  14. Nivolumab in combination with chemotherapy in the treatment of oesophagus and stomach cancer added

  15. Added the EAMS SO for Tepotinib

  16. Removed Risdiplam from list as the EAMS SO has expired

  17. Added 'Cipaglucosidase alfa with miglustat in the treatment of late-onset Pompe disease'

  18. New EAMS scientific opinion issued to Aventis Pharma Ltd t/a Sanofi for avalglucosidase alfa in the treatment of late- and infantile-onset Pompe disease.

  19. Lumasiran in the treatment of primary hyperoxaluria type 1 (PH1) in all age groups removed

  20. Added new EAMS scientific opinion 'Abrocitinib in the treatment of severe atopic dermatitis'.

  21. Added 'Nivolumab with ipilimumab in the treatment of malignant pleural mesothelioma' to current EAMS

  22. Addition of EAMS for Pemigatinib in the treatment of cholangioarcinoma

  23. Removed 'Dupilumab in the treatment of children aged 6 to 11 years of age with severe atopic dermatitis (allergic eczema)'.

  24. Removed 'Nivolumab as monotherapy treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal, squamous cell carcinoma (OSCC) after prior fluoropyrimidine- and platinum-based chemotherapy'

  25. Expired early access to medicine scientific opinion due to granting of marketing authorisation

  26. Added berotralstat to the current EAMS

  27. Removal of scientific opinion for Raxone due to discontinuation of EAMS programme at the request of the company

  28. Added new document - Risdiplam in the treatment of patients 2 months of age and older with type 1 and type 2 spinal muscular atrophy (SMA) - in Current EAMS

  29. Added link to 'Early access to medicines scheme (EAMS) scientific opinion: Avelumab in the treatment of bladder cancer'

  30. Updated EAMS SO

  31. Added Lumasiran in the treatment of primary hyperoxaluria type 1 (PH1) in all age groups to the list of current EAMS

  32. Remdesivir has been removed from the list of current EAMS

  33. Added the decision: Atezolizumab in combination with bevacizumab for the treatment of adult patients with unresectable hepatocellular carcinoma who have received no prior systemic therapy

  34. The scientific opinion for Nivolumab for treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal cancer after prior chemotherapy was added to Current EAMS.

  35. Added Early access to medicines scheme (EAMS) scientific opinion on Remdesivir to list

  36. Removed entry - 'Early access to medicines scheme (EAMS) scientific opinion: tafamidis for the treatment of transthyretin amyloidosis in adult patients with wild type or hereditary cardiomyopathy to reduce all-cause mortality and cardiovascular-related hospitalisation'

  37. The EAMS Scientific Opinion for polatuzumab vedotin in combination with bendamustine and rituximab for the treatment of relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in adult patients who are not eligible for hematopoietic stem cell transplant has been removed from this page due to the granting of the EU licence

  38. Added new decision - Early access to medicines scheme (EAMS) scientific opinion: Isatuximab in combination with pomalidomide and dexamethasone for adult patients.

  39. Added new EAMS scientific opinion for Avelumab in combination with axitinib for first-line treatment of advanced renal cancer.

  40. New EAMS Scientific Opinion added to the page. This EAMS is for polatuzumab vedotin in combination with bendamustine and rituximab for the treatment of relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in adult patients who are not eligible for hematopoietic stem cell transplant.

  41. Added a new scientific opinion for Atezolizumab

  42. New EAMS scientific opinion on Tafamidis for the treatment of transthyretin amyloidosis added to the page.

  43. Added the EAMS scientific opinion on Atezolizumab as 1st line treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours have PD-L1 expression ≥ 1%

  44. Added the positive scientific opinion for Dupilumab as a treatment of adolescent patients between 12 and 18 years of age with severe atopic dermatitis for whom the available systemic therapies are not suitable.

  45. Added new EAMs scientific opinion: Atezolizumab as a treatment of metastatic non-squamous non-small cell lung cancer (NSCLC) with EGFR/ALK mutations

  46. Added patisiran-LNP to treat adults with hereditary transthyretin-mediated amyloidosis.

  47. Early Access to Medicines Scientific Opinion on Volanesorsen to treat adult patients with familial chylomicronaemia syndrome

  48. Amended to add the positive scientific opinion for emicizumab for routine prophylaxis of bleeding episodes in patients, aged 1 year and over, with haemophilia A with factor VIII inhibitors

  49. Added Nivolumab to treat advanced or recurrent gastric or gastroesophageal junction cancer after two or more systemic therapies to current EAMS opinions.

  50. Removed Dupilumab (for severe atopic dermatitis) from current EAMS as this product received a marketing authorisation from the European Commission.

  51. Link to the EAMS Scientific Opinion for Alectinib has been added to the page.

  52. New EAMS scientific opinion for Raxone added to the collections page.

  53. New EAMS scientific opinion for Oxervate added to the page.

  54. Added EAMS scientific opinion: Glecaprevir/Pibrentasvir for the treatment of chronic hepatitis C (HCV) infection in adults

  55. EAMS for Dupilumab published

  56. SO for pembrolizumab for non-small cell lung cancer removed from current EAMS list.

  57. New EAMS positive scientific opinion

  58. Nivolumab to treat a type of cancer of the Lymph system - the Scientific Opinion has now expired due to a positive EC decision

  59. Added link to the scientific opinion: venetoclax for the treatment of chronic lymphocytic leukaemia (CLL)

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

  61. New EAM issued to Novartis for sacubitril-valsartan

  62. First published.

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