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SMC ID Date Medicine Submission Type Indication
SMC2346 12/04/2021 acalabrutinib (Calquence) Abbreviated

As monotherapy or in combination with obinutuzumab for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL)

SMC2348 12/04/2021 acalabrutinib (Calquence) Abbreviated

As monotherapy for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy

SMC2303 12/04/2021 isatuximab (Sarclisa) Full

In combination with pomalidomide and dexamethasone for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor, and have demonstrated disease progression on the last therapy.

SMC2322 12/04/2021 dapagliflozin (Forxiga) Full

In adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction.

SMC2313 12/04/2021 galcanezumab (Emgality) Full

Prophylaxis of migraine in adults who have at least 4 migraine days per month

SMC2317 12/04/2021 dupilumab (Dupixent) Full

In adults and adolescents 12 years and older as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fractional exhaled nitric oxide (FeNO), who are inadequately controlled with high dose inhaled corticosteroid (ICS) plus another medicinal product for maintenance treatment.

SMC2327 12/04/2021 ataluren (Translarna) Ultra-orphan initial assessment

Treatment of Duchenne muscular dystrophy resulting from a nonsense mutation in the dystrophin gene, in ambulatory patients aged 2 years and older.

SMC2311 08/03/2021 onasemnogene abeparvovec (Zolgensma) Full

For the treatment of:

  • patients with 5q spinal muscular atrophy (SMA) with a bi-allelic mutation in the survival motor neuron 1 (SMN1) gene and a clinical diagnosis of SMA type 1, or
  • patients with 5q SMA with a bi-allelic mutation in the SMN1 gene and up to three copies of the SMN2 gene
SMC2335 08/03/2021 beclometasone dipropionate/formoterol fumarate dehydrate/glycopyrronium bromide (Trimbow) Abbreviated

Maintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and medium dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year.

SMC2332 08/03/2021 doravirine (Pifeltro) Abbreviated

In combination with other antiretroviral medicinal products, for the treatment of adults infected with human immunodeficiency virus 1 (HIV-1) without past or present evidence of resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class.

SMC2333 08/03/2021 doravirine/lamivudine/tenofovir disoproxil fumarate (Delstrigo) Abbreviated

For the treatment of adults infected with human immunodeficiency virus 1 (HIV-1) without past or present evidence of resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, lamivudine, or tenofovir.

SMC2328 08/03/2021 trametinib (Mekinist) Abbreviated

For treatment in combination with dabrafenib (Tafinlar) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. This is an abbreviated submission to remove the SMC restriction to first-line treatment.

SMC2295 08/03/2021 entrectinib (Rozlytrek) Full

For the treatment of adult and paediatric patients 12 years of age and older, with solid tumours that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion:

  • who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and
  • who have not received a prior NTRK inhibitor
  • who have no satisfactory treatment options
SMC2340 08/02/2021 apremilast (Otezla) Non submission

Treatment of adult patients with oral ulcers associated with Behçet’s disease who are candidates for systemic therapy.

SMC2341 08/02/2021 glasdegib (Daurismo) Non submission

In combination with low-dose cytarabine, for the treatment of newly diagnosed de novo or secondary acute myeloid leukaemia (AML) in adult patients who are not candidates for standard induction chemotherapy.

SMC2339 08/02/2021 alpelisib (Piqray) Non submission

In combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with a PIK3CA mutation after disease progression following endocrine therapy as monotherapy.

SMC2344 08/02/2021 omalizumab (Xolair) Non submission

As add-on therapy with intranasal corticosteroids (INC) for the treatment of adults (18 years and above) with severe chronic rhinosinusitis with nasal polyps for whom therapy with INC does not provide adequate disease control.

SMC2343 08/02/2021 mercaptamine (Cystadrops) Non submission

Treatment of corneal cystine crystal deposits in adults and children from 2 years of age with cystinosis.

SMC2316 08/02/2021 buprenorphine/naloxone (Suboxone) Abbreviated

Substitution treatment for opioid drug dependence, within a framework of medical, social and psychological treatment. The intention of the naloxone component is to deter intravenous misuse. Suboxone is indicated in adults and adolescents over 15 years of age who have agreed to be treated for addiction.

SMC2320 08/02/2021 leuprorelin acetate (Prostap DCS) Abbreviated

As treatment in pre- and perimenopausal women with advanced breast cancer suitable for hormonal manipulation.

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Publication due date SMC meeting date Medicine Submission Type Indication
10/05/2021 upadacitinb (Rinvoq) Abbreviated

For the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. Upadacitinib may be used as monotherapy or in combination with methotrexate

10/05/2021 indacaterol/mometasone furoate (Atectura Breezhaler) Abbreviated

As maintenance treatment of asthma in adults and adolescents 12 years of age and older not adequately controlled with inhaled corticosteroids and inhaled short acting beta2-agonists

10/05/2021 indacaterol/glycopyrronium/mometasone furoate (Enerzair Breezhaler) Abbreviated

As maintenance treatment of asthma in adult patients not adequately controlled with a maintenance combination of a long acting beta2 agonist and a high dose of an inhaled corticosteroid who experienced one or more asthma exacerbations in the previous year.

10/05/2021 upadacitinib (Rinvoq) Abbreviated

For the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. Upadacitinib may be used as monotherapy or in combination with methotrexate

10/05/2021 06/04/2021 encorafenib (Braftovi) Full

In combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, who have received prior systemic therapy.

14/06/2021 vigabatrin (Kigabeq) Abbreviated

In infants and children from 1 month to less than 7 years of age for:

  • treatment in monotherapy of infantile spasms (West's syndrome)

  • treatment in combination with other antiepileptic medicinal products for patients with resistant partial epilepsy (focal onset seizures) with or without secondary generalisation, that is where all other appropriate medicinal product combinations have proved inadequate or have not been tolerated.
14/06/2021 5-aminolevulinic acid (Alacare) Abbreviated

Single use treatment of mild actinic keratoses lesions with a maximum diameter of 1.8 cm on the face and scalp (hairless areas).

14/06/2021 04/05/2021 baricitinib (Olumiant) Full

Treatment of moderate to severe atopic dermatitis in adult patients who are candidates for systemic therapy.

14/06/2021 04/05/2021 acalabrutinib (Calquence) Full

As monotherapy or in combination with obinutuzumab for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL)

14/06/2021 04/05/2021 trifluridine/tipiracil (Lonsurf) Full

As monotherapy for the treatment of adult patients with metastatic gastric cancer including adenocarcinoma of the gastroesophageal junction, who have been previously treated with at least two prior systemic treatment regimens for advanced disease.

14/06/2021 04/05/2021 nintedanib (Ofev) Full

Treatment in adults of other chronic fibrosing interstitial lung diseases with a progressive phenotype.

14/06/2021 04/05/2021 mogamulizumab (Poteligeo) Full

For the treatment of adult patients with mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least one prior systemic therapy.

12/07/2021 pertuzumab/trastuzumab (Phesgo) Abbreviated

In combination with chemotherapy in:

  • the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence
  • the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence

In combination with 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.

12/07/2021 01/06/2021 atezolizumab (Tecentriq) Full

In combination with bevacizumab for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy.

12/07/2021 01/06/2021 tafamidis (Vyndaqel) Full

For the treatment of wild‑type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM)

09/08/2021 06/07/2021 avatrombopag (Doptelet) Full

For the treatment of primary chronic immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).

Q2 2021 Q2 2021 chlormethine hydrochloride (Ledaga) Full

Topical treatment of mycosis fungoides-type cutaneous T-cell lymphoma (MF-type CTCL) in adult patients.

Q2 2021 Q2 2021 ravulizumab (Ultomiris) Full

Treatment of patients with a body weight of 10kg or above with atypical haemolytic uremic syndrome (aHUS) who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab.

Q2 2021 Q2 2021 niraparib (Zejula) Full

As monotherapy for the maintenance treatment of adult patients with advanced epithelial (FIGO Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.

TBC 02/10/2018 padeliporfin (TOOKAD) Full Indicated as monotherapy for adult patients with previously untreated, unilateral, low-risk, adenocarcinoma of the prostate with a life expectancy ≥ 10 years and: - Clinical stage T1c or T2a, - Gleason Score ≤ 6, based on high-resolution biopsy strategies, - PSA ≤ 10 ng/mL, - 3 positive cancer cores with a maximum cancer core length of 5 mm in any one core or 1-2 positive cancer cores with ≥ 50 % cancer involvement in any one core or a PSA density ≥ 0.15 ng/mL/cm3.
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