Expired early access to medicines scheme scientific opinions
Updated 31 May 2024
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Dostarlimab in combination with platinum-containing chemotherapy for the treatment of adult patients with mismatch repair deficient (dMMR) / microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer and who are candidates for systemic therapy.
Company: GlaxoSmithKline UK Limited
EAMS SO granted: 29 June 2023
EAMS SO expired: 04 April 2024
Indication: Dostarlimab in combination with platinum-containing chemotherapy for the treatment of adult patients with mismatch repair deficient (dMMR) / microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer and who are candidates for systemic therapy.
Glofitamab, as monotherapy, in the treatment of adult patients with relapsed or refractory diffuse large Bcell lymphoma (DLBCL), after two or more lines of systemic therapy.
Company: Roche Products Limited
EAMS SO granted: 30 June 2023
EAMS SO expired: 16 October 2023
Indication: Glofitamab in the treatment of diffuse large B-cell lymphoma (DLBCL)
Cipaglucosidase alfa in conjunction with miglustat in the long-term treatment of adult symptomatic patients with confirmed diagnosis of late-onset Pompe disease (acid α-glucosidase [GAA] deficiency) who have received enzyme replacement therapy with alglucosidase alfa for ≥ 2 years.
Company: Amicus Therapeutics UK Limited
EAMS SO granted: 04/06/2021
EAMS SO expired: 30/06/2023
Indication: Cipaglucosidase alfa with miglustat in the treatment of late-onset Pompe disease
Risankizumab in the treatment of moderately to severely active Crohn’s disease
Company: AbbVie Ltd
EAMS SO granted: 13/04/2022
EAMS SO expired: 13/04/2023
Indication: Risankizumab in the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to, lost response to, or were intolerant or contraindicated to tumour necrosis factor-alpha (TNFα) antagonist therapies, vedolizumab and ustekinumab and for the treatment of adolescent patients aged 16 to 17 years with moderately to severely active Crohn’s disease who have had an inadequate response to, lost response to, or were intolerant or contraindicated to TNFα antagonist therapies
Lutetium (177Lu) vipivotide tetraxetan in the treatment of prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC)
Company: Advanced Accelerator Applications
EAMS SO granted: 05/04/2022
EAMS SO expired: 31/03/2023
Indication: lutetium (177Lu) vipivotide tetraxetan in the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy or who are not medically suitable for taxanes.
Efgartigimod alfa in the treatment of myasthenia gravis (gMG)
Company: argenx BVadd
EAMS SO granted: 25/05/2022
EAMS SO expired: 14/03/2023
Indication: treatment of adults with generalised Myasthenia Gravis (gMG), an autoimmune disease that causes muscle weakness. gMG can affect multiple muscle groups throughout the body.
Ascimib in the treatment of adult patients with a blood cancer called Philadelphia chromosome-positive chronic myeloid leukaemia in chronic phase that does not have a gene defect (T315I mutation) and who have previously received treatment with at least two medicines named tyrosine kinase inhibitors.
Company: Novartis Pharmaceuticals UK Limited
EAMS SO granted: 11 January 2022
EAMS SO expired: 12 December 2022
Indication: Asimib in the treatment of chronic myeloid leukaemia
Voxelotor in the treatment of sickle cell disease
Company: Global Blood Therapeutics UK Limited
EAMS SO granted: 25 January 2022
EAMS SO expired: 25 July 2022
Indication: Voxeltor in the treatment of sickle cell disease
Abrocitinib in the treatment of severe atopic dermatitis
Company: Pfizer Limited
EAMS SO granted: 28 January 2021
EAMS SO expired: 8 September 2021
Indication: abrocitinib in the treatment of adult and adolescent patients with severe atopic dermatitis who have not responded to approved treatments or who are ineligible or intolerant to approved treatments.
Avalglucosidase alfa in the treatment of Pompe disease
Company: Aventis Pharma Ltd t/a Sanofi
EAMS SO granted: 5 March 2021
EAMS SO expired: 6 July 2022
Indication: Avalglucosidase alfa in the treatment of Pompe disease
Berotralstat in the routine prevention of recurrent attacks of hereditary angioedema (HAE) in adult and adolescent patients aged 12 years and older.
Company: BioCryst UK Limited
EAMS SO granted: 30/10/2020
EAMS SO expired: 12/05/2021
Indication: routine prevention of recurrent attacks of hereditary angioedema (HAE) in adults and adolescents aged 12 years and older.
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.
Company: Bristol-Myers Squibb Pharma
EAMS SO granted: 13/08/2021
EAMS SO expired: 01/11/2021
Indication: nivolumab in combination with chemotherapy for the treatment of cancer of the stomach or oesophagus (gullet) that has spread beyond the stomach or oesophagus
Tepotinib in the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harbouring mesenchymal-epithelial transition factor gene (MET) exon 14 (METex14) skipping alterations
Company: Merck Serono Limited
EAMS SO granted: 12/07/2021
EAMS SO expired: 24/09/2021
Indication: tepotinib in the treatment of advanced non-small cell lung cancer (NSCLC)
Nivolumab in combination with ipilimumab in the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM).
Company: Bristol-Myers Squibb Pharmaceuticals Limited
EAMS SO granted: 27/01/2021
EAMS SO expired: 26/07/2021
Indication: Nivolumab with ipilimumab in the treatment of malignant pleural mesothelioma
Risdiplam in the treatment of patients 2 months of age and older with type 1 and type 2 spinal muscular atrophy (SMA) who are not suitable for authorised treatments.
Company: Roche Products Limited
EAMS SO granted: 17/09/2020
EAMS SO expired: 01/07/2021
Risdiplam in the treatment of type 1 and type 2 spinal muscular atrophy (SMA) in patients 2 months of age and older
Pemigatinib in the treatment of cholangioarcinoma
Company: Incyte Biosciences UK Ltd
EAMS SO granted: 15/01/2021
EAMS SO expired: 07/04/2021
Indication: Treatment of adults with locally advanced or metastatic cholangiocarcinoma with fibroblast growth factor receptor 2 fusion or rearrangement that is relapsed or refractory after at least one line of systemic therapy.
Lumasiran in the treatment of primary hyperoxaluria type 1 (PH1) in all age groups
Company: Alnylam UK Limited
EAMS SO granted: 10/07/2020
EAMS SO expired: 19/11/2020
Indication: EAMS scientific opinion issued to Alnylam UK Limited for lumasiran in the treatment of primary hyperoxaluria type 1 (PH1) in all age groups.
Avelumab in the treatment of bladder cancer
Company: Merck Serono Limited
EAMS SO granted: 1/09/2020
EAMS SO expired: 21/01/2021
Indication: avelumab in the treatment of adults with bladder cancer that has spread beyond the bladder (advanced urothelial carcinoma) if the cancer did not get worse after chemotherapy
Dupilumab
Company: Sanofi
EAMS SO granted: 14/08/2020
EAMS SO expired: 25/11/2020
Indication: Dupilumab in the treatment of children aged 6 to 11 years of age with severe atopic dermatitis (allergic eczema)
SO public assessment report: Dupilumab
Nivolumab
Company: Bristol-Myers Squibb Pharmaceuticals Ltd
EAMS SO granted: 05/06/2020
EAMS SO expired: 23/11/2020
Indication: Nivolumab for treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal cancer after prior chemotherapy
SO public assessment report: Nivolumab
Atezolizumab
Company: Roche Products Limited
EAMS SO granted: 18/6/2020
EAMS SO expired: 1/11/2020
Indication: atezolizumab in combination with bevacizumab for the treatment of adult patients with unresectable hepatocellular carcinoma who have received no prior systemic therapy
SO public assessment report: Atezolizumab
Raxone (to treat the decline of respiratory function in patients with Duchenne Muscular Dystrophy)
Company: Santhera Pharmaceuticals
EAMS SO granted: 21/06/2017
EAMS SO expired: 12/10/2020
Indication: Raxone to treat the decline of respiratory function in patients with Duchenne Muscular Dystrophy
SO public assessment report: Raxone
Remdesivir (for SARS-CoV-2 infection)
Company: Gilead Sciences Ltd.
EAMS SO granted: 26/05/2020
EAMS SO expired: 03/07/2020
Indication: Remdesivir in the treatment of patients hospitalised with suspected or laboratory-confirmed SARS-CoV-2 infection who meet the clinical criteria
SO public assessment report: Remdesivir
Isatuximab (for relapsed and refractory multiple myeloma)
Company: Aventis Pharma
EAMS SO granted: 02/12/2019
EAMS SO expired: 05/06/2020
Indication: Isatuximab in combination with pomalidomide and dexamethasone for the treatment of adult patients with relapsed and refractory multiple myeloma
Tafamidis (for amyloid cardiomyopathy)
Company: Pfizer Limited
EAMS SO granted: 24/05/2019
EAMS SO expired: 17/02/2020
Indication: Indicated for the treatment of transthyretin amyloidosis in adult patients with wild-type or hereditary cardiomyopathy to reduce all-cause mortality and cardiovascular-related hospitalisation.
SO public assessment report: Tafamidis (for amyloid cardiomyopathy)
Polatuzumab vedotin (for non-Hodgkin Lymphoma)
Company: Roche Products Limited
EAMS SO granted: 25/06/2019
EAMS SO expired: 27/01/2020
Indication: For the treatment of relapsed/refractory diffuse large B-cell lymphoma (DLBCL)
SO public assessment report: Polatuzumab vedotin (for non-Hodgkin Lymphoma)
Avelumab (for kidney cancer)
Company: Merck Serono Ltd
EAMS SO granted: 12/07/2019
EAMS SO expired: 24/10/2019
Indication: The first-line treatment of adult patients with advanced renal cell carcinoma (RCC).
SO public assessment report: Avelumab (for kidney cancer)
Atezolizumab (for lung cancer)
Company: Roche Products Limited
EAMS SO granted: 07/06/2019
EAMS SO expired: 06/09/2019
Indication: In combination with carboplatin and etoposide, for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).
SO public assessment report: Atezolizumab (for lung cancer)
Atezolizumab (for breast cancer)
Company: Roche Products Limited
EAMS SO granted: 11/03/2019
EAMS SO expired: 26/08/2019
Indication: As 1st line treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours have PD-L1 expression ≥ 1%
SO public assessment report: Atezolizumab (for breast cancer)
Dupixent (for dermatitis)
Company: Sanofi
EAMS SO granted: 23/01/2019
EAMS SO expired: 13/08/2019
Indication: Treatment of adolescent patients between 12 and 18 years of age with severe atopic dermatitis for whom the available systemic therapies are not suitable
SO public assessment report: Dupixent (for dermatitis)
Volanesorsen (Rare genetic lipid disorder)
Company: Akcea Therapeutics UK Ltd
EAMS SO granted: 04 June 2018
EAMS SO expired: 03 May 2019
Indication: Treatment of adult patients with familial chylomicronaemia syndrome
SO public assessment report: Volanesorsen (Rare genetic lipid disorder)
Atezolizumab (for lung cancer)
Company: Roche Products Limited
EAMS SO granted: 21 December 2018
EAMS SO expired: 7 March 2019
Indication: In combination with bevacizumab, paclitaxel and carboplatin, treatment of adult patients with metastatic non-squamous non-small cell lung cancer (NSCLC) with EGFR activating or ALK positive tumour mutations after failure of appropriate targeted therapies
SO public assessment report: Atezolizumab (for lung cancer)
Patisiran-LNP (To treat adults with hereditary transthyretin-mediated amyloidosis)
Company: Alnylam UK Limited
EAMS SO granted: 2 August 2018
EAMS SO expired: 27 August 2018
Indication: To treat adults with hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis).
SO public assessment report: Patisiran-LNP - Public assessment report
Nivolumab (for gastric cancer)
Company: Bristol-Myers Squibb Pharmaceutical Limited
EAMS SO granted: 21 December 2017
EAMS SO expired: 16 August 2018
Indication: Treatment of advanced or recurrent gastric or gastroesophageal junction adenocarcinoma after two or more systemic therapies
SO public assessment report: Nivolumab - Public assessment report
Additional information: The company has informed the MHRA that it has withdrawn from the drug licensing process and the EAMS. The EAMS will close to new patients on the 16 August 2018.
More information about the withdrawal from the drug licensing process can be found on the EMA webpage
Emicizumab - for routine prophylaxis of bleeding episodes in patients, aged 1 year and over, with haemophilia A with factor VIII inhibitors
Company: Roche Products Limited
EAMS SO granted: 29/12/2017
EAMS SO expired: 28/02/2018
Indication: Indicated for routine prophylaxis of bleeding episodes in patients, aged 1 year and over, with haemophilia A with factor VIII inhibitors
SO public assessment report: Emicizumab - Public assessment report
Alectinib (as monotherapy for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC))
Company: Roche products limited
EAMS SO granted: 1 September 2017
EAMS SO expired: 21 December 2017
Indication: As monotherapy for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC)
SO public assessment report: Alectinib - Public assessment report
Dupilumab (for severe atopic dermatitis)
Company: Sanofi
EAMS SO granted: 10 March 2017
EAMS SO expired: 27 September 2017
Indication: For the purpose of EAMS, dupilumab is being made available to adult patients with severe atopic dermatitis who have failed to respond, or who are intolerant of or ineligible for all approved therapies. Dupilumab can be used with or without topical corticosteroids
SO public assessment report: Dupilumab (for severe atopic dermatitis)
Glecaprevir/Pibrentasvir (for the treatment of chronic hepatitis C (HCV) infection in adults)
Company: Abbvie Ltd
EAMS SO granted: 09 May 2017
EAMS SO expired: 26 July 2017
Indication: Treatment of chronic hepatitis C (HCV) infection in adults
SO public assessment report: Glecaprevir/Pibrentasvir (for the treatment of chronic hepatitis C (HCV) infection in adults)
Oxervate (for moderate or severe neurotrophic keratitis)
Company: Dompe
EAMS SO granted: 02 June 2017
EAMS SO expired: 06 July 2017
Indication: Treatment of moderate or severe neurotrophic keratitis
SO public assessment report: Oxervate for the treatment of moderate or severe neurotrophic keratitis - Public Assessment Report
Atezolizumab (for bladder cancer)
Company: Roche Products Limited
EAMS SO granted: 20 January 2017
EAMS SO expired: 12 June 2017
Indication: Treatment of adult patients with locally advanced or metastatic urothelial carcinoma after disease progression following one prior platinum-containing chemotherapy regimen regardless of its setting (neoadjuvant, adjuvant, or metastatic)
SO public assessment report: Atezolizumab (for bladder cancer) Public Assessment Report Treatment protocol for patients Treatment protocol for Healthcare Professionals Treatment protocol on the pharmacovigilance system
Pembrolizumab (for lung cancer)
Company: Merck Sharp & Dohme Limited
EAMS SO granted: 10 March 2016
EAMS SO expired: 31 January 2017
Indication: Treatment as monotherapy of adults with metastatic non-small cell lung cancer (NSCLC) whose tumours express PD-L1 as determined by a validated test and who have not received prior systemic therapy and are negative for EGFR sensitising mutation and ALK translocation.
SO public assessment report: Pembrolizumab for Lung Cancer Public Assessment Report
Venetoclax (for chronic lymphocytic leukaemia)
Company: Abbvie Ltd
EAMS SO granted: 23 August 2016
EAMS SO expired: 5 December 2016
Indication: To treat a type of blood cancer in adults known as chronic lymphocytic leukaemia
SO public assessment report: Venetoclax for chronic lymphocytic leukaemia Public Assessment Report
Nivolumab (to treat a type of cancer of the lymph system)
Company: Bristol-Myers Squibb Pharmaceutical Limited
EAMS SO granted: 03 November 2016
EAMS SO expired: 21 November 2016
Indication: Treatment of Hodgkin lymphoma.
SO public assessment report: Nivolumab to treat a type of cancer of the lymph system public assessment report
Pembrolizumab (for lung cancer)
Company: Merck Sharp & Dohme Limited
EAMS SO granted: 10 March 2016
EAMS SO expired: 29 July 2016
Indication: Treatment as monotherapy of adults with metastatic non-small cell lung cancer (NSCLC) whose tumours express PD-L1 as determined by a validated test and whose disease has progressed on or after platinum-containing chemotherapy. Patients who have an EGFR sensitising mutation or an ALK translocation should also have had disease progression on approved therapies for these aberrations prior to receiving pembrolizumab.
SO public assessment report: Pembrolizumab (for non-small cell lung cancer)
Nivolumab (for Kidney Cancer)
Company: Bristol-Myers Squibb Pharmaceutical Limited
EAMS SO granted: 11 February 2016
EAMS SO expired: 4 April 2016
Indication: Treatment of renal cell carcinoma
SO public assessment report: Nivolumab (for Kidney Cancer) EAMS public assessment report
Nivolumab (for lung cancer)
Company: Bristol-Myers Squibb Pharmaceutical Limited
EAMS SO granted: 5 February 2016
EAMS SO expired: 4 April 2016
Indication: Treatment of non-squamous non-small cell lung cancer
SO public assessment report: Nivolumab (for lung cancer) EAMS public assessment report
Osimertinib (for lung cancer)
Company: AstraZeneca UK Limited
EAMS SO granted: 04 December 2015
EAMS SO expired: 02 February 2016
Indication: 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.
SO public assessment report: Osimertinib EAMS public assessment report
Sacubitril/valsartan (for heart failure)
Company: Novartis Pharmaceuticals UK Ltd
EAMS SO granted: 1 September 2015
EAMS SO expired: 19 November 2015
Indication: To reduce the risk of cardiovascular mortality and morbidity in adult patients with symptomatic heart failure and reduced ejection fraction.
SO public assessment report: Sacubitril/valsartan EAMS public assessment report
Nivolumab (for lung cancer)
Company: Bristol-Myers Squibb Pharmaceutical Limited
EAMS SO granted: 19 June 2015
EAMS SO expired: 20 July 2015
Indication: Treatment of advanced lung cancer (characterised by squamous non-small cells), which has spread or cannot be removed by surgery following other cancer chemotherapies
SO public assessment report: Nivolumab (for lung cancer) EAMS public assessment report
Pembrolizumab (for melanoma)
Company: Merck Sharp & Dohme Limited
EAMS SO granted: 9 March 2015
EAMS SO expired: 17 July 2015
Indication: Treatment of advanced melanoma (a type of skin cancer affecting cells called melanocytes), which has spread or cannot be removed by surgery and has progressed after other treatments.
SO public assessment report: Pembrolizumab (MK-3475) EAMS public assessment report
Nivolumab (for melanoma)
Company: Bristol-Myers Squibb Pharmaceutical Limited
EAMS SO granted: 29 May 2015
EAMS SO expired: 19 June 2015
Indication: Treatment of advanced (unresectable or metastatic) melanoma in adults
SO public assessment report: Nivolumab EAMS public assessment report