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SMC ID Date Medicine Indication
SMC2136 11/02/2019 cabozantinib (Cabometyx) treatment of advanced renal cell carcinoma (RCC) in treatment-naïve adults with intermediate or poor risk per IMDC criteria
SMC2114 11/02/2019 axicabtagene ciloleucel (Yescarta) for treating relapsed or refractory diffuse large B-cell non-Hodgkin lymphoma
SMC2129 11/02/2019 tisagenlecleucel (Kymriah) Treatment of paediatric and young adult patients up to 25 years with B-cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse
SMC2162 11/02/2019 doravirine (Pifeltro) In combination with other antiretroviral medicinal products, for the treatment of adults infected with human immunodeficiency virus 1 without past or present evidence of resistance to the non-nucleoside reverse transcriptase inhibitor class.
SMC2163 11/02/2019 doravirine/lamivudine/tenofovir disoproxil (Delstrigo) Treatment of adults infected with human immunodeficiency virus 1 without past or present evidence of resistance to the non-nucleoside reverse transcriptase inhibitor class, lamivudine, or tenofovir.
SMC2122 11/02/2019 tofacitinib (Xeljanz) For the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to conventional therapy or a biologic agent
SMC2126 11/02/2019 romiplostim (Nplate) Chronic immune (idiopathic) thrombocytopenic purpura patients one year of age and older who are refractory to other treatments (e.g. corticosteroids, immunoglobulins)
SMC2128 11/02/2019 rivaroxaban (Xarelto) Co-administered with acetylsalicylic acid (ASA) for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events
SMC2131 11/02/2019 dabrafenib (Tafinlar) In combination with trametinib is indicated for the adjuvant treatment of adult patients with Stage III melanoma with a BRAF V600 mutation, following complete resection
SMC2087 11/02/2019 eslicarbazepine acetate (Zebinix) For adjunctive therapy in adolescents and children aged above 6 years with partial-onset seizures with or without secondary generalisation.
SMC2161 11/02/2019 dexmedetomidine (Dexdor) Sedation of non-intubated adult patients prior to and/or during diagnostic or surgical procedures requiring sedation, i.e. procedural/awake sedation.
SMC2160 11/02/2019 cabozantinib (Cabometyx) As monotherapy for the treatment of hepatocellular carcinoma in adults who have previously been treated with sorafenib.
SMC2127 11/02/2019 pembrolizumab (Keytruda) In combination with pemetrexed and platinum chemotherapy for the first-line treatment of metastatic non-squamous NSCLC in adults whose tumours have no EGFR or ALK positive mutations
SMC2092 14/01/2019 semaglutide (Ozempic) Treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise.
SMC2102 14/01/2019 ertugliflozin (Steglatro) In adults aged 18 years and older with T2DM as an adjunct to diet and exercise to improve glycaemic control: • As monotherapy in patients for whom the use of metformin is considered inappropriate due to intolerance or contraindications. • In addition to other medicinal products for the treatment of diabetes.
SMC2116 14/01/2019 tofacitinib (Xeljanz) In combination with MTX is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior disease modifying antirheumatic drug (DMARD) therapy.
SMC2025 14/01/2019 arsenic trioxide (Trisenox) In combination with all-trans-retinoic acid (ATRA [tretinoin]) for the 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), 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
SMC2120 14/01/2019 pertuzumab (Perjeta) For use in combination with trastuzumab and docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.
SMC2118 14/01/2019 tiotropium (Spiriva Respimat) As add-on maintenance bronchodilator treatment in patients aged 6 years and older with severe asthma who experienced one or more severe asthma exacerbations in the preceding year.
SMC2112 10/12/2018 nivolumab (Opdivo) as monotherapy is indicated for the adjuvant treatment of adults with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.
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Advice due date SMC meeting date Medicine Indication
11/03/2019 05/06/2018 letermovir (Prevymis) Prophylaxis of cytomegalovirus (CMV) reactivation and disease in adult CMV-seropositive recipients [R+] of an allogeneic haematopoietic stem cell transplant
11/03/2019 05/02/2019 liposomal formulation of daunorubicin & cytarabine (Vyxeos) Treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes (AMC-MRC)
11/03/2019 05/02/2019 tisagenlecleucel (Kymriah) 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
08/04/2019 05/03/2019 erenumab (Aimovig) for the prophylaxis of migraine in adults who have at least 4 migraine days per month
08/04/2019 05/03/2019 mepolizumab (Nucala) Add-on therapy for children (6y+), adolescents, and adults with severe refractory eosinophilic asthma
08/04/2019 05/03/2019 testosterone (Testavan) For replacement therapy for adult male hypogonadism, when testosterone deficiency has been confirmed by clinical features and biochemical tests.
08/04/2019 05/03/2019 certolizumab pegol (Cimzia) Treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy
08/04/2019 05/03/2019 blinatumomab (Blincyto) as monotherapy for the treatment of paediatric patients aged 1 year or older with Philadelphia chromosome negative CD19 positive B-cell precursor ALL which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic hematopoietic stem cell transplantation
08/04/2019 05/03/2019 rufinamide (Inovelon) as adjunctive therapy in the treatment of seizures associated with Lennox-Gastaut syndrome in patients 1 years of age and older
13/05/2019 02/04/2019 doxylamine succinate and pyridoxine hydrochloride (Xonvea) for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management
13/05/2019 02/04/2019 latanoprost + timolol (Fixapost) 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.
13/05/2019 02/04/2019 abemaciclib (Verzenios) Women with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy
13/05/2019 02/04/2019 abemaciclib (Verzenios) For the treatment of women with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer in combination with fulvestrant as initial endocrine-based therapy or in women who have received prior endocrine therapy
13/05/2019 02/04/2019 pembrolizumab (Keytruda) as monotherapy for the adjuvant treatment of adults with stage III melanoma and lymph node involvement who have undergone complete resection
13/05/2019 02/04/2019 cariprazine (Reagila) for the treatment of schizophrenia in adult patients
10/06/2019 07/05/2019 benralizumab (Fasenra) As add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting β-agonists.
10/06/2019 07/05/2019 fluticasone/formoterol (Flutiform) 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.
Q2 2019 Q2 2019 lenvatinib (Lenvima) as monotherapy for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have received no prior systemic therapy
Q2 2019 Q2 2019 patisiran (Onpattro) For the treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy.
Q3 2019 Q2 2019 encorafenib (Braftovi) encorafenib in combination with binimetinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation
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