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SMC ID Date Medicine Submission Type Indication
SMC2291 07/06/2021 ramucirumab (Cyramza) Non submission

In combination with erlotinib is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer with activating epidermal growth factor receptor (EGFR) mutations

SMC2353 07/06/2021 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).

SMC2347 07/06/2021 acalabrutinib (Calquence) Full

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

SMC2337 07/06/2021 baricitinib (Olumiant) Full

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

SMC2336 07/06/2021 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.

SMC2331 07/06/2021 nintedanib (Ofev) Full

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

SMC2329 07/06/2021 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.

SMC2352 07/06/2021 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.

SMC2330 10/05/2021 ravulizumab (Ultomiris) Full

For the 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.

SMC2318 10/05/2021 chlormethine hydrochloride (Ledaga) Full

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

SMC2377 10/05/2021 glycopyrronium/formoterol fumarate dihydrate (Bevespi Aerosphere) Non submission

Maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease.

SMC2361 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

SMC2356 10/05/2021 indacaterol/mometasone furoate (Atectura Breezhaler) Abbreviated

As a 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

SMC2355 10/05/2021 indacaterol/glycopyrronium/mometasone furoate (Enerzair Breezhaler) Abbreviated

As a 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.

SMC2338 10/05/2021 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.

SMC2312 10/05/2021 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.

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.

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Publication due date SMC meeting date Medicine Submission Type Indication
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)

12/07/2021 ofatumumab (Kesimpta) Full

For the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features

12/07/2021 01/06/2021 bempedoic acid (Nilemdo) Resubmission

For treatment in adults with primary hypercholesterolaemia (heterozygous familial and non‑familial) or mixed dyslipidaemia, as an adjunct to diet:

  • in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL‑C goals with the maximum tolerated dose of a statin
    or
  • alone or in combination wtih other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.
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).

09/08/2021 06/07/2021 autologous anti-CD19-transduced CD3+ cells (KTE-X19) (Tecartus) Full

For the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after two or more lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor

09/08/2021 06/07/2021 nivolumab (Opdivo) Full

As monotherapy for the treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine and platinum-based combination chemotherapy

09/08/2021 06/07/2021 avelumab (Bavencio) Full

As monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who are progression-free following platinum-based chemotherapy

09/08/2021 06/07/2021 inclisiran (Leqvio) Full

For the treatment of adults with primary hypercholesterolaemia (heterozygous familial and non‑familial) or mixed dyslipidaemia, as an adjunct to diet

  • in combination with a statin or statin with other lipid‑lowering therapies in patients unable to reach LDL‑C goals with the maximum tolerated dose of a statin, or
  • alone or in combination with other lipid‑lowering therapies in patients who are statin‑intolerant, or for whom a statin is contraindicated
09/08/2021 06/07/2021 guselkumab (Tremfya) Full

For the treatment of active psoriatic arthritis in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy, alone or in combination with methotrexate (MTX).

13/09/2021 03/08/2021 amikacin (Arikayce) Full

Non-tuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium Complex (MAC) in adults with limited treatment options who do not have cystic fibrosis. Consideration should be given to official guidance on the appropriate use of antibacterial agents.

13/09/2021 03/08/2021 selpercatinib (Retsevmo) Full

Adults and adolescents 12 years and older with advanced RET-mutant medullary thyroid cancer (MTC) who require systemic therapy following prior treatment with cabozantinib and/or vandetanib.
Adults with advanced RET fusion-positive thyroid cancer (TC) who require systemic therapy following prior treatment with lenvatinib and/or sorafenib.

13/09/2021 03/08/2021 olaparib (Lynparza) Full

As monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer and BRCA1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent.

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.
TBC TBC buprenorphine and naloxone (Zubsolv) Abbreviated Substitution treatment for opioid drug dependence.
TBC oritavancin (Orbactiv) Full

For the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults.

TBC 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 high dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year.

TBC TBC olaparib (Lynparza) Full

In combination with bevacizumab for the maintenance treatment of adult patients with advanced (FIGO stages III and IV) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a BRCA1/2 mutation and/or genomic instability.

TBC TBC selpercatinib (Retsevmo) Full

As monotherapy for the treatment of adults with advanced rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.

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