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SMC ID Date Medicine Submission Type Indication
SMC2219 12/08/2019 pomalidomide (Imnovid) Non submission

In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide.

SMC2217 12/08/2019 lenalidomide (Revlimid) Non submission

As combination therapy with bortezomib and dexamethasone for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.

SMC2183 12/08/2019 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.

SMC2188 12/08/2019 inotersen (Tegsedi) Full

For the treatment of stage 1 or stage 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis (hATTR).

SMC2169 12/08/2019 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.

SMC2167 12/08/2019 tildrakizumab (Ilumetri) Full

Treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy.

SMC2172 12/08/2019 perampanel (Fycompa) Abbreviated

Adjunctive treatment of partial-onset seizures with or without secondarily generalised seizures in patients with epilepsy aged 12 years and older.

SMC2166 12/08/2019 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.

SMC1236/17 12/08/2019 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

SMC2182 12/08/2019 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.

SMC2221 12/08/2019 rucaparib (Rubraca) Non submission

As monotherapy treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum based chemotherapy, and who are unable to tolerate further platinum based chemotherapy.

SMC2218 12/08/2019 perampanel (Fycompa) Non submission

For the adjunctive treatment of primary generalised tonic-clonic seizures in adult and adolescent patients from 12 years of age with idiopathic generalised epilepsy.

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.
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

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

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.

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.

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

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)

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.
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Publication due date SMC meeting date Medicine Submission Type Indication
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 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 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 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 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 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 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.
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.
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 triptorelin acetate (Decapeptyl) Full Triptorelin (Decapeptyl SR 3 mg), a gonadotropin-releasing-hormone (GnRH) agonist, is indicated as adjuvant treatment, in combination with tamoxifen or an aromatase inhibitor, of endocrine responsive early stage breast cancer in women at high risk of recurrence who are confirmed as pre-menopausal after completion of chemotherapy.
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.
11/11/2019 01/10/2019 pentosan polysulfate sodium (Elmiron) Full

For the treatment of adults with bladder pain syndrome characterised by either glomerulations or Hunner’s lesions with moderate to severe pain, urgency and frequency of micturition.

11/11/2019 01/10/2019 trientine tetrahydrochloride (Cuprior) Abbreviated For the treatment of Wilson's disease in adults, adolescents and children ≥ 5 years intolerant to D-penicillamine therapy.
11/11/2019 01/10/2019 imiquimod (Zyclara) Full Topical treatment of clinically typical, nonhyperkeratotic, nonhypertrophic, visible or palpable actinic keratosis (AK) of the full face or balding scalp in immunocompetent adults when other topical treatment options are contraindicated or less appropriate.
11/11/2019 01/10/2019 clostridium botulinum neurotoxin type A (Xeomin) Full Adult patients with chronic sialorrhoea due to neurological conditions.
11/11/2019 01/10/2019 glecaprevir/pibrentasvir (Maviret) Abbreviated For treatment of chronic hepatitis C virus (HCV) infection in adults and in adolescents aged 12 to <18 years.
09/12/2019 05/11/2019 voretigene neparvovec (Luxturna) Ultra-orphan initial assessment

For the treatment of adult and paediatric patients with vision loss due to inherited retinal dystrophy caused by confirmed biallelic RPE65 mutations and who have sufficient viable retinal cells.

09/12/2019 05/11/2019 lusutrombopag (Mulpleo) Full

For the treatment of severe thrombocytopenia in adult patients with chronic liver disease undergoing invasive procedures.

Q3 2019 Q3 2019 axicabtagene ciloleucel (Yescarta) Resubmission Treatment of adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) and primary mediastinal large B cell lymphoma (PMBCL), after two or more lines of systemic therapy.
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