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SMC ID Date Medicine Submission Type Indication
SMC2434 08/11/2021 durvalumab (Imfinzi) Non submission

Durvalumab in combination with etoposide and either carboplatin or cisplatin for the first-line treatment of adults with extensive-stage small cell lung cancer.

SMC2436 08/11/2021 olaparib (Lynparza) Non submission

As monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have HER2 negative locally advanced or metastatic breast cancer. Patients should have previously been treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless patients were not suitable for these treatments.

SMC2435 08/11/2021 olaparib (Lynparza) Non submission

As monotherapy for the maintenance treatment of adult patients with germline BRCA1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen.

SMC2437 08/11/2021 sebelipase alfa (Kanuma) Non submission

Long-term enzyme replacement therapy (ERT) in patients of all ages with lysosomal acid lipase (LAL) deficiency.

SMC2433 08/11/2021 asfotase alfa (Strensiq) Non submission

Long-term enzyme replacement therapy in patients with paediatric-onset hypophosphatasia to treat the bone manifestations of the disease.

SMC2380 08/11/2021 pembrolizumab (Keytruda) Full

As monotherapy is indicated for the treatment of adult and paediatric patients aged 3 years and older with relapsed or refractory classical Hodgkin lymphoma who have failed autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT is not a treatment option.

SMC2379 08/11/2021 atezolizumab (Tecentriq) Full

As monotherapy is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have a PD-L1 expression ≥ 50% tumour cells (TC) or ≥ 10% tumour-infiltrating immune cells (IC) and who do not have epidermal growth factor receptor (EGFR) mutant or anaplastic lymphoma kinase (ALK)-positive NSCLC.

SMC2383 08/11/2021 osimertinib (Tagrisso) Full

Adjuvant treatment after complete tumour resection in adult patients with stage IB-IIIA non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations.

SMC2371 08/11/2021 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.

SMC2410 08/11/2021 bimekizumab (Bimzelx) Abbreviated

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

SMC2384 08/11/2021 ponesimod (Ponvory) Abbreviated

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

SMC2366 11/10/2021 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.

SMC2386 11/10/2021 cabozantinib (Cabometyx) Abbreviated

in combination with nivolumab for the first-line treatment of advanced renal cell carcinoma in adults

SMC2396 11/10/2021 empagliflozin (Jardiance) Abbreviated

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

SMC2378 11/10/2021 liraglutide (Saxenda) Full

As an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial Body Mass Index (BMI) of

  • ≥30 kg/m² (obese), or
  • ≥27 kg/m² to <30 kg/m² (overweight) in the presence of at least one weight-related comorbidity such as dysglycaemia (pre-diabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia or obstructive sleep apnoea.
SMC2406 11/10/2021 bempedoic acid/ezetimibe (Nustendi) Abbreviated

Adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet

  • in combination with a statin in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin in addition to ezetimibe
  • alone in patients who are either statin-intolerant or for whom a statin is contraindicated, and are unable to reach LDL-C goals with ezetimibe alone
  • in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets with or without statin.
SMC2425 11/10/2021 vericiguat (Verquvo) Non submission

For treatment of symptomatic chronic heart failure in adult patients with reduced ejection fraction who are stabilised after a recent decompensation event requiring IV therapy.

SMC2423 11/10/2021 isatuximab (Sarclisa) Non submission

in combination with carfilzomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.

SMC2392 11/10/2021 midazolam (Ozalin) Abbreviated

in children from 6 months to 17 years old, for moderate sedation before a therapeutic or diagnostic procedure or as premedication before anaesthesia.

SMC2424 11/10/2021 avapritinib (Ayvakyt) Non submission

As monotherapy for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumours (GIST) harbouring the platelet-derived growth factor receptor alpha (PDGFRA) D842V mutation.

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Publication due date SMC meeting date Medicine Submission Type Indication
13/12/2021 02/11/2021 amikacin (Arikayce) Resubmission

Treatment of non-tuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium Complex (MAC) in adults with limited treatment options who do not have cystic fibrosis.

13/12/2021 olopatadine hydrochloride and mometasone furoate monohydrate (Ryaltris) Abbreviated

In adults and adolescents 12 years of age and older for the treatment of moderate to severe nasal symptoms associated with allergic rhinitis

13/12/2021 02/11/2021 ibrutinib (Imbruvica) Full

As a single agent for the treatment of adult patients with Waldenström's macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.

13/12/2021 02/11/2021 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.

13/12/2021 02/11/2021 tafamidis (Vyndaqel) Resubmission

Treatment of wild type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM).

13/12/2021 TBC nivolumab (Opdivo) Full

nivolumab with ipilimumab (NIVO+IPI) is indicated for the treatment of adults with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-based combination chemotherapy.

13/12/2021 TBC tirbanibulin (Klisyri) Full

Field treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis (Olsen grade 1) of the face or scalp in adults.

13/12/2021 07/09/2021 buprenorphine implant (Sixmo) Full

Substitution treatment for opioid dependence in clinically stable adult patients who require no more than 8 mg/day of sublingual buprenorphine, within a framework of medical, social and psychological treatment.

17/01/2022 budesonide (Cortiment) Abbreviated

Induction of remission in patients with active microscopic colitis (MC)

17/01/2022 opicapone (Ongentys) Abbreviated

Adjunctive therapy to preparations of levodopa / DOPA decarboxylase inhibitors in adult patients with Parkinson's disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations.

17/01/2022 07/12/2021 osimertinib (Tagrisso) Resubmission

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.

17/01/2022 07/12/2021 trastuzumab deruxtecan (Enhertu) Full

As monotherapy for the treatment of adult patients with unresectable or metastatic HER2 positive (HER2+) breast cancer who have received two or more prior anti-HER2-based regimens.

17/01/2022 07/12/2021 nivolumab (Opdivo) Full

In combination with ipilimumab and 2 cycles of platinum-based doublet chemotherapy (PDC) is indicated for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) in adults whose tumours have no sensitising epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) translocations.

17/01/2022 07/12/2021 dostarlimab (Jemperli) Full

Monotherapy for the treatment of adult patients with recurrent or advanced mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) endometrial cancer (EC) that has progressed on or following prior treatment with a platinum‑containing regimen.

14/02/2022 11/01/2022 cannabidiol (Epidyolex) Full

As adjunctive therapy of seizures associated with tuberous sclerosis complex (TSC) for patients 2 years of age and older.

14/02/2022 11/01/2022 pemigatinib (Pemazyre) Full

As monotherapy for the treatment of adults with locally advanced or metastatic cholangiocarcinoma (CCA) with a fibroblast growth factor receptor 2 (FGFR2) gene fusion or rearrangement that have progressed after at least one prior line of systemic therapy.

14/02/2022 11/01/2022 enzalutamide (Xtandi) Full

For treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy.

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.

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