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SMC ID Date Medicine Submission Type Indication
SMC2115 08/07/2019 darvadstrocel (Alofisel) Full Treatment of complex perianal fistula(s) in adult patients with non-active/mildly active luminal Crohn’s disease (CD), when fistula(s) have shown an inadequate response to at least one conventional or biologic therapy.
SMC2149 08/07/2019 palbociclib (Ibrance) Full for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer -in combination with fulvestrant in women who have received prior endocrine therapy
SMC2145 08/07/2019 encorafenib (Braftovi) Full encorafenib in combination with binimetinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation
SMC2180 08/07/2019 daratumumab (Darzalex) Full In combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
SMC2181 08/07/2019 arsenic trioxide (Trisenox) Resubmission

For induction of remission and consolidation in adult patients with: • Newly diagnosed, low-to-intermediate risk acute promyelocytic leukaemia (APL) (white blood cell count, ≤10 x 103/µl) in combination with all-trans-retinoic acid (ATRA) • Relapsed/refractory APL (previous treatment should have included a retinoid and chemotherapy) characterised by the presence of the t(15;17) translocation and/or the presence of the Pro-Myelocytic Leukaemia/Retinoic-Acid-Receptor-alpha (PML/RAR-alpha) gene.
SMC2156 10/06/2019 durvalumab (Imfinzi) Full as monotherapy for the treatment of locally advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express programmed cell death ligand 1 (PD-L1) on ≥1% of tumour cells (TCs) and whose disease has not progressed following platinum-based chemoradiation therapy (CRT)
SMC2154 10/06/2019 fingolimod (Gilenya) Abbreviated As single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult patients and paediatric patients aged 10 years and older: Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4.4 and 5.1 of the SmPC), Or: Patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.
SMC2203 10/06/2019 golimumab (Simponi) Non submission In combination with methotrexate for the treatment of polyarticular juvenile idiopathic arthritis in children 2 years of age and older who have responded inadequately to previous therapy with methotrexate.
SMC2202 10/06/2019 brentuximab vedotin (Adcetris) Non submission Treatment of adult patients with previously untreated CD30+ Stage IV Hodgkin lymphoma in combination with doxorubicin, vinblastine and dacarbazine.
SMC2201 10/06/2019 alirocumab (Praluent) Non submission In adults with established atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors: • in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies or, • alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.
SMC2178 10/06/2019 fluticasone/formoterol (Flutiform) Abbreviated For the licence extension of low strength flutiform (50/5 µg) in children aged 5 to <12 years. This fixed-dose combination of fluticasone propionate and formoterol fumarate (flutiform inhaler) is indicated in the regular treatment of asthma where the use of a combination product (an inhaled corticosteroid and a long-acting β2 agonist) is appropriate: o For patients not adequately controlled with inhaled corticosteroids and ‘as required’ inhaled short-acting β2 agonist. Or o For patients already adequately controlled on both an inhaled corticosteroid and a long-acting β2 agonist. flutiform 50 microgram/5 microgram inhaler is indicated in adults, adolescents and children aged 5 years and above.
SMC2155 10/06/2019 benralizumab (Fasenra) Full As add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting β-agonists.
SMC2147 10/06/2019 brigatinib (Alunbrig) Full as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase positive (ALK+) advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib
SMC2157 10/06/2019 patisiran (Onpattro) Full For the treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy.
SMC2153 10/06/2019 nivolumab (Opdivo) Full In combination with ipilimumab for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma.
SMC2137 13/05/2019 cariprazine (Reagila) Full for the treatment of schizophrenia in adult patients.
SMC2159 13/05/2019 latanoprost + timolol (Fixapost) Abbreviated Reduction of intraocular pressure (IOP) in patients with open angle glaucoma and ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues.
SMC2144 13/05/2019 pembrolizumab (Keytruda) Full as monotherapy for the adjuvant treatment of adults with stage III melanoma and lymph node involvement who have undergone complete resection
SMC2193 13/05/2019 rituximab (MabThera) Non submission Treatment of patients with moderate to severe pemphigus vulgaris.
SMC2191 13/05/2019 daratumumab (Darzalex) Non submission In combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
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Publication due date SMC meeting date Medicine Submission Type Indication
12/08/2019 02/07/2019 inotersen (Tegsedi) Full For the treatment of stage 1 or stage 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis (hATTR).
12/08/2019 02/07/2019 venetoclax (Venclyxto) Full In combination with rituximab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy.
12/08/2019 02/07/2019 lumacaftor-ivacaftor (Orkambi) Full For the treatment of cystic fibrosis (CF) in patients aged 2 years and older who are homozygous for the F508del mutation in the CFTR gene.
12/08/2019 02/07/2019 tezacaftor-ivacaftor (Symkevi) Full In a combination regimen with ivacaftor 150 mg tablets for the treatment of patients with cystic fibrosis (CF) aged 12 years and older who are homozygous for the F508del mutation or who are heterozygous for the F508del mutation and have one of the following mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272-26A→G, and 3849+10kbC→T.
12/08/2019 02/07/2019 tildrakizumab (Ilumetri) Full Treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy.
12/08/2019 02/07/2019 buprenorphine (Buvidal) Full For the treatment of opioid dependence within a framework of medical, social and psychological treatment. Treatment is intended for use in adults and adolescents aged 16 years or over.
12/08/2019 02/07/2019 perampanel (Fycompa) Abbreviated Adjunctive treatment of partial-onset seizures with or without secondarily generalised seizures in patients with epilepsy aged 12 years and older.
12/08/2019 04/04/2017 empaglifozin linagliptin fixed-dose combination (Glyxambi) Abbreviated Indicated in adults aged 18 years and older with type 2 diabetes mellitus: to improve glycaemic control when metformin and/or sulphonylurea (SU) and one of the monocomponents of Glyxambi do not provide adequate glycaemic control when already being treated with the free combination of empagliflozin and linagliptin
09/09/2019 06/08/2019 zanamivir (Dectova) Abbreviated Treatment of complicated and potentially life-threatening influenza A or B virus infection in adult and paediatric patients (aged ≥ 6 months) when: • The patient’s influenza virus is known or suspected to be resistant to anti-influenza medicinal products other than zanamivir, and/or • Other anti-viral agents for treatment of influenza, including inhaled zanamivir, are not suitable for the individual patient.
09/09/2019 06/08/2019 dolutegravir lamivudine (Dovato) Abbreviated Treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults and adolescents above 12 years of age weighing at least 40 kg, with no known or suspected resistance to the integrase inhibitor class, or lamivudine.
09/09/2019 06/08/2019 osimertinib (Tagrisso) Full As monotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations.
09/09/2019 06/08/2019 pembrolizumab (Keytruda) Full In combination with carboplatin and either paclitaxel or nab-paclitaxel, is indicated for the first-line treatment of metastatic squamous NSCLC in adult.
09/09/2019 06/08/2019 dacomitinib (Vizimpro) Full As monotherapy, for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)-activating mutations.
09/09/2019 06/08/2019 ospemifene (Senshio) Full For the treatment of moderate to severe symptomatic vulvar and vaginal atrophy in post-menopausal women who are not candidates for local vaginal oestrogen therapy.
09/09/2019 06/08/2019 tisagenlecleucel (Kymriah) Resubmission For the treatment of adult patients with relapsed or refractory (r/r) diffuse large B cell lymphoma (DLBCL) after two or more lines of systemic therapy.
09/09/2019 06/08/2019 melatonin (Slenyto) Full Treatment of insomnia in children and adolescents aged 2-18 with autism spectrum disorder (ASD) and / or Smith-Magenis syndrome, where sleep hygiene measures have been insufficient.
09/09/2019 06/08/2019 dapagliflozin (Forxiga) Full In adults for the treatment of insufficiently controlled T1DM as an adjunct to insulin in patients with BMI ≥ 27 kg/m2, when insulin alone does not provide adequate glycaemic control despite optimal insulin therapy.
07/10/2019 03/09/2019 enzalutamide (Xtandi) Full For the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (nmCRPC). High-risk is defined as prostate specific antigen (PSA) doubling time (PSADT) ≤10 months and PSA ≥2 ng/mL.
07/10/2019 03/09/2019 pertuzumab (Perjeta) Full In combination with trastuzumab and chemotherapy for the adjuvant treatment of adult patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer (eBC) at high risk of recurrence.
07/10/2019 03/09/2019 risankizumab (Skyrizi) Full For the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
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